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Beta\\-carotene crystal and/or other carotenoids to liquid CWD formulation and/or oil suspension.\n\n\nTasks related to order and cleanliness of the workstation.\n\n\nMaintenance tasks described in the SOPs specific to the position and in autonomous maintenance checklists and support for Maintenance personnel.\n\n\nParticipate in continuous improvement activities such as monitoring indicators, proposals, and improvement events.\n\n\nActively participate in compliance with safety and environmental requirements and related events such as safety/environmental meetings and reporting of unsafe conditions.\n\n### **2\\.** **Position context**\n\n \n\nResponsible for carrying out the described operations and recording required data on operation sheets and work instructions, following direct instructions given by the shift supervisor and operations and quality control supervisors.\n\n\nResponsible for operating plant and laboratory equipment and facilities according to work instructions and maintaining them in appropriate cleaning conditions.\n\n### **3\\.** **Position content**\n\n \n\n* + - * Plant/DCS operation: open and close manual and automatic valves, operate control loops\n\t\t\t* Start-up/Shut-down/checking operation of the following equipment on site:\n* Starch loading hopper\n* Tanks on oil and powder production lines\n* Auxiliary equipment on oil and powder production lines\n* + - * Loading crystals.\n\t\t\t* Loading starch.\n\t\t\t* Cleaning of equipment and facilities.\n\t\t\t* Transporting waste generated at the workstation to the collection point.\n\t\t\t* Data acquisition/input into the computer system.\n\t\t\t* Process analytical control.\n \n\n### **4\\.** **Complexity of the position**\n\n \n\nLow level of initiative and autonomy\n\n\nLow work difficulty\n\n\nNo supervisory responsibility\n\n \n\n### **5\\.** **Knowledge and educational level**\n\n \n\nLaboratory analyst.\n\n\nChemical Plant Operator.\n\n\nTraining in Safety and Hygiene.\n\n\nFood Handling Training.\n\n### **6\\.** **SHE Requirements**\n\n\nTheoretical and Practical Training in Emergency Plan\n\n\nFire Fighting Training: Use of extinguishers, fire hose stations (BIE), hydrants, SCBA\n\n\nTraining in use of Personal Protective Equipment specific to the job position\n\n\nRisks and Preventive Measures related to forklifts\n\n\nManual handling of loads\n\n\nHandling and storage of chemicals, CLP Regulation hygiene, labeling, MSDS and waste handling\n\n\nSafety data sheets of handled products\n\n\nDSM SHE Policy\n\n\nLSR Life Saving Rules\n\n\nJob position risks\n\n\nZone Classification training\n\n\nWork permit procedure\n\n\nLockout procedure\n\n\nSegregate and store generated waste.\n\n\nMinimize to the maximum extent possible the potential impacts arising from activities.\n\n\nReport to the Department Manager any potential environmental incidents/accidents, as well as critical situations that could lead to future environmental deficiencies.\n\n### **7\\.** 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of standard producing procedures under cGMPs regulations, as a part of the work team.\n \nProduction operations associated to their department will include, among others, chromatographic resin and column handling, as well as direct and tangential filtration systems, intermediate product handling, excipients and solutions preparation, and equipment and material preparation.\n \n \n\n**Responsibilities:** \n\n* Execute Protein Purification activities in accordance with specifications from Research and Development department and quality standards of Company.\n* Write Standard Operating Procedures (SOPs) corresponding to equipment and tasks of their department.\n* Write Batch Records documents.\n* Production equipment preparation prior to use as well as after use (cleaning, sanitization, etc.).\n* Register all production activities in logbooks, batch records (BRs) or documentation according to guidelines and quality procedures of company.\n* Preparation of media, buffers and process 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Global impact. Bridge to thousands of biopharma companies and their patients. \n\nWe are PCI. \n\nOur investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. \n\nThe Level I Production Operator (Technician I) learns and executes the aseptic batch manufacturing activities, billable activities or continuous improvement that are required in the production department, following the instructions and standard operating procedures in accordance with the AEMPS, FDA and other regulatory agencies under supervision. Ensuring the execution of production plans, while following all the company's safety guidelines.* Comply with manufacturing area safety regulations and work practices in accordance with all company Health, Safety and Environmental programs.\n* Work as a team, being approachable, practical, motivating, able to support and inspire your co\\-workers.\n* Participation in the \"Quarterly conversation\"\n* Comply with the schedule by following the prioritization instructions of their senior managers to ensure compliance with the schedules together with the department head.\n* Collaborate in the identification of opportunities for continuous improvement to improve processes and practices.\n* Comply with the requirements of cGMP, AEMPS, FDA and other regulatory agencies that have been implemented in the plant, as well as with the department's objectives and corporate quality standards.\n* Collaborate and participate in preparing for inspections by regulatory agencies or clients.\n* Participate in the control of the stock of plant consumables, to guarantee their availability.\n* Collaborate in the investigations of the different quality events (deviations, CAPAs, change controls...).\n* Inform the direct manager when anomalies are detected in the operation of equipment, as well as human errors, both their own and those of the team's personnel, in order to ensure the quality of the product manufactured.\n* Inform the direct manager if safety equipment or human resources needs are identified.\n* Collaborate in teamwork with other departments if required.\n* Take care of and ensure the proper functioning of the equipment\n* Operate production equipment following the guidelines indicated in the work procedures\n* Participate in the manufacture of the different products following the indications of the Manufacturing Guides and complying with GMP regulations.\n* Handle pallet trucks for the movement of goods.\n* Demonstrate a general knowledge of aseptic techniques\n* Successful participation in the gowning qualification as well as the Media Fill plan\n* Review relevant SOPs and production lot records, as needed.\n* Complete and maintain documentation related to assigned work, including notebooks, batch records, etc\n* Comply with and maintain cleanliness and order of production areas in accordance with appropriate standard operating procedures.\n* Perform the activities of dispensing and preparing materials to be used in the activities of the department.\n* Perform the sanitization of materials prior to their introduction into the manufacturing areas\n* Disinfect and clean production rooms\n* Supports the activities of formulation processes\n* Supports the activities of the activities of filtration processes\n* Supports the activities of the processes of preparation of autoclave cycles and assembly of installations\n* Supports the activities of the qualification of Production equipments.\n* Operate production equipment following the guidelines indicated in the work procedures\n* Perform cleaning of production equipment\n* Supports the manufacture of the different products following the indications of the Manufacturing Guides and complying with GMP regulations.\n* Supports the activities of SIP execution of sterilizable equipment\n\n\nJoin us and be part of building the bridge between life changing therapies and patients. Let’s talk future\nEqual Employment Opportunity (EEO) Statement: \n\n*PCI Pharma Services is an Equal* *Opportunity/Affirmative* *Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.**At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life\\-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. 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Location:
Leon
Category:
Quality Assurance & Control

Indeed
MAINTENANCE TECHNICIAN (M/F) PORTIS LEON
Date Posted:
2025\-11\-12
Country:
Spain
Location:
C/ Azorín, 26 Bajo, 24010 San Andrés del Rabanedo (León)
Would you like to become part of a stable sector with many professional opportunities?
PORTIS, a national leader in the automatic doors industry, is hiring AUTOMATIC DOOR TECHNICIANS in LEÓN.
As an AUTOMATIC DOOR TECHNICIAN, your responsibilities will include:* Performing preventive and corrective maintenance tasks on assigned routes.
* Identifying new business opportunities with new customers to grow the customer portfolio and business.
* Providing service to assigned customers.
To succeed in this role, we require:
EDUCATION: Higher Vocational Training (FPII) or equivalent. Welding, electricity, electronics, and metal locksmithing knowledge will be valued.
Previous training in Occupational Health and Safety (PRL) (50\-60h), as well as holding elevated platform and forklift operator licenses, will also be considered advantageous.
PREVIOUS EXPERIENCE: Essential previous experience in preventive/corrective maintenance and/or installation of automatic doors of at least 1 year. Direct customer interaction experience and social skills to identify business opportunities will be valued.
LANGUAGES: Native-level Spanish is essential. Additional languages will be an advantage.
COMPUTER SKILLS: User or advanced level in full Microsoft Office suite.
OTHERS:* Valid class B driver's license is essential.
Would you like to join a true international company driven by talent that values Safety, Ethics, Quality, Innovation, and Employee Opportunities?
We are looking for committed professionals who prioritize safety, feel comfortable working both independently and within teams, and who are curious and adaptable.
If you live in a city, chances are we will give you a lift or play a role in keeping you moving every day.
Otis is the world’s leading elevator and escalator manufacturing, installation, and service company. We move 2\.4 billion people every day and maintain approximately 2\.4 million customer units worldwide, the industry's largest Service portfolio.
You may recognize our products in some of the world’s most famous landmarks including the Eiffel Tower, Empire State Building, Burj Khalifa and the Petronas Twin Towers! We are 72,000 people strong, including engineers, digital technology experts, sales, and functional specialists, as well as factory and field technicians, all committed to meeting the diverse needs of our customers and passengers in more than 200 countries and territories worldwide. We are proud to be a diverse, global team with a proven legacy of innovation that continues to be the bedrock of a fast\-moving, high\-performance company.
When you join Otis, you become part of an innovative global industry leader with a resilient business model. You’ll belong to a diverse, trusted, and caring community where your contributions, and the skills and capabilities you’ll gain working alongside the best and brightest, keep us connected and on the cutting edge.
We provide opportunities, training, and resources, that build leadership and capabilities in Sales, Field, Engineering and Major Projects and our Employee Scholar Program is a notable point of pride, through which Otis sponsors colleagues to pursue degrees or certification programs.
Today, our focus more than ever is on people. As a global, people\-powered company, we put people – passengers, customers, and colleagues – at the center of everything we do. We are guided by our values that we call our Three Absolutes – prioritizing Safety, Ethics, Quality in all that we do. If you would like to learn more about environmental, social and governance (ESG) at Otis click here.
Become a part of the Otis team and help us \#Buildwhatsnext!*Otis is An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other protected class according to applicable law. To request an accommodation in completing an employment application due to a special need or a disability, please contact us at careers@otis.com.*

C. de Azorín, 28, 24191 San Andrés del Rabanedo, León, Spain

Indeed
Head of Sourcing CU WEU
**Join our Team**
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**About this opportunity:**
Ericsson is looking for a Head of Sourcing for Customer Unit West Europe (CU WEU) in Market Area EMEA. This role plays a critical part in how we partner with suppliers and deliver third\-party solutions to our customers in a rapidly evolving telecom landscape. You will lead sourcing strategy across multiple countries, ensuring speed, cost\-effectiveness, and long\-term value creation.
This position is about leading a distributed team, building sourcing capabilities, and acting as a key interface between business stakeholders and the supplier ecosystem. You will work closely with delivery, commercial, and category teams to enable business readiness, manage risk, and unlock supplier innovation to support Ericsson’s growth.
The Head of Sourcing for Customer Unit (CU) West Europe reports directly to the Head of Sourcing EMEA. This role is a key member of the EMEA Sourcing Leadership Team. The role leads a team of Sourcing Business Partners and Strategic Sourcing Managers across countries under CU WEU’s remit.
**Key Responsibilities:**
* Be end\-to\-end sourcing accountability toward the business, covering all third\-party procurement (3PP), even when execution is shared across sourcing teams.
* Through early and proactive engagement, collaborate with Stakeholders and Sourcing functions, translating product/customer solution requirements into strategies and third\-party business solutions, managing sourcing plans, driving cost and delivery performance.
* Ensure effective management of total spend, drive excellence in cost, supplier efficiency and quality in line with the profitability targets of the company
* Drive the Sourcing compliance \& EHS agenda across the unit and the entire supplier base, managing risk and ensure preventative actions
* Promote business opportunities based on optimized value extraction through partnering, supplier innovation, market insight and Sourcing strategies.
* Actively engage and support EMEA Domains, Sourcing Category teams as well as other Market Area stakeholders on specific sales opportunities and business readiness requirements.
* Drive supplier business intelligence, benchmarking practice \& category market knowledge, establishing a cost effective \& competitive marketplace
* Define and drive Sourcing vision, strategy, and related targets in alignment with stakeholders and category strategies.
* Build a high performing team and set ways of working that are efficient and effective following Ericsson’s leadership framework.
* Uncompromising Integrity – Strong need to be an impartial party that looks to the best possible solution for Ericsson
* Demonstrate and role model the Ericsson core values, and ethical and responsible business practices.
**What you will bring:**
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* Degree in Administration, Economics or Technology or equivalent through experience
* 10\+ years Sourcing experience in various sourcing domains of which 3\+ years in leadership roles.
* Deep experience in Telecommunications
* Sourcing Practice, Process \& Strategy Knowledge
* Proven leadership behaviors, including leading diverse and cross countries teams
* Strong negotiations skills
* Ability to influence internal and external partners and drive objective decision making
**Occasional travel is required.**
**Why join Ericsson?**
At Ericsson, you´ll have an outstanding opportunity. The chance to use your skills and imagination to push the boundaries of what´s possible. To build solutions never seen before to some of the world’s toughest problems. You´ll be challenged, but you won’t be alone. You´ll be joining a team of diverse innovators, all driven to go beyond the status quo to craft what comes next.
**What happens once you apply?**
Click Here to find all you need to know about what our typical hiring process looks like.
Encouraging a diverse and inclusive organization is core to our values at Ericsson, that's why we champion it in everything we do. We truly believe that by collaborating with people with different experiences we drive innovation, which is essential for our future growth. We encourage people from all backgrounds to apply and realize their full potential as part of our Ericsson team. Ericsson is proud to be an Equal Opportunity Employer. learn more.
**Primary country and city: Based in one of the CU WEU countries. Final location and employment terms will be confirmed during the selection process.**
**Req ID:** 769975

León, Spain

Indeed
ANALISTA DE CONTROL DE CALIDAD-SECCIÓN ESTABILIDADES
Overview:
Sample and analyze, using different analytical techniques (GC, HPLC, TLC, KF), API, intermediate samples or final samples, completing the work bulletins each product and perform verifications of HPLC, GC, KF, Analytical Balances; GMP's according to the Rules, the Standard Operating Procedures (PNT's) guidelines concerning the weekly cleaning of the work area and the superior; in order to ensure good quality (meet the specifications) of different products, ensure good functioning of equipment and facilitate decision\-making of superiors. All this taking into account the safety regulations indicated by the company and the use of personal protective equipment provided depending on the risks of each operation.
Responsibilities:
* Analyze, using different analytical techniques (GC, HPLC, TLC, KF), API, or final samples, in order to ensure good quality (meet the specifications) of different products.
* Complete analytical documentation for each product to meet GMP
* Perform the analytical transfers and training of QC analysts in the new methods
* Perform verification of HPLC, GC, KF, analytical balances and other laboratory equipment to confirm their good performance.
* Store and control of stock chemical reagents, following established rules to ensure order and location.
* Maintenance and cleaning of laboratory equipment.
* Follow approved analytical methods and SOP in place.
* Train the new incorporations in the specific activities and functions of the position in which you are an expert.
Qualifications:
* **Education:** A bachelor´s degree in Sciences.
* **Languages:** Fluent Spanish, medium level English is a plus.
* **Experience (years/area):** Minimum 1 year experience in the functions mentioned above is recommended. Experience in HPLC, GC, Physico\-chemical
* **Specific Knowledge:** Experience in GMP environment, knowledge in FDA is a plus.
* **Travels:** Open to travel occasionally.
* **Personal skills:** Able to work independently, prioritize and meet project timelines, be strongly self\-motivated and able to motivate a team. Ability to work in a fast\-paced environment and manage multiple competing demands.

Lugar Villasinta, 1007, 24193 Villasinta de Torío, León, Spain

Indeed
Analista control de calidad-sección estabilidades
Overview:
Sample and analyze, using different analytical techniques (GC, HPLC, TLC, KF), API, intermediate samples or final samples, completing the work bulletins each product and perform verifications of HPLC, GC, KF, Analytical Balances; GMP's according to the Rules, the Standard Operating Procedures (PNT's) guidelines concerning the weekly cleaning of the work area and the superior; in order to ensure good quality (meet the specifications) of different products, ensure good functioning of equipment and facilitate decision\-making of superiors. All this taking into account the safety regulations indicated by the company and the use of personal protective equipment provided depending on the risks of each operation.
Responsibilities:
* Analyze, using different analytical techniques (GC, HPLC, TLC, KF), API, or final samples, in order to ensure good quality (meet the specifications) of different products.
* Complete analytical documentation for each product to meet GMP
* Perform the analytical transfers and training of QC analysts in the new methods
* Perform verification of HPLC, GC, KF, analytical balances and other laboratory equipment to confirm their good performance.
* Store and control of stock chemical reagents, following established rules to ensure order and location.
* Maintenance and cleaning of laboratory equipment.
* Follow approved analytical methods and SOP in place.
* Train the new incorporations in the specific activities and functions of the position in which you are an expert.
Qualifications:
Innovation, customer orientation, communication, teamwork, adaptability/flexibility, productivity, Self\-development, sense of urgency, initiative.

Lugar Villasinta, 1007, 24193 Villasinta de Torío, León, Spain

Indeed
Senior Operator Production TTH Leon
### **1\.** **Purpose of the position**
Process from Beta\-carotene crystal and/or other carotenoids to liquid CWD formulation and/or oil suspension.
Tasks related to order and cleanliness of the workstation.
Maintenance tasks described in the SOPs specific to the position and in autonomous maintenance checklists and support for Maintenance personnel.
Participate in continuous improvement activities such as monitoring indicators, proposals, and improvement events.
Actively participate in compliance with safety and environmental requirements and related events such as safety/environmental meetings and reporting of unsafe conditions.
### **2\.** **Position context**
Responsible for carrying out the described operations and recording required data on operation sheets and work instructions, following direct instructions given by the shift supervisor and operations and quality control supervisors.
Responsible for operating plant and laboratory equipment and facilities according to work instructions and maintaining them in appropriate cleaning conditions.
### **3\.** **Position content**
* + - * Plant/DCS operation: open and close manual and automatic valves, operate control loops
* Start-up/Shut-down/checking operation of the following equipment on site:
* Starch loading hopper
* Tanks on oil and powder production lines
* Auxiliary equipment on oil and powder production lines
* + - * Loading crystals.
* Loading starch.
* Cleaning of equipment and facilities.
* Transporting waste generated at the workstation to the collection point.
* Data acquisition/input into the computer system.
* Process analytical control.
### **4\.** **Complexity of the position**
Low level of initiative and autonomy
Low work difficulty
No supervisory responsibility
### **5\.** **Knowledge and educational level**
Laboratory analyst.
Chemical Plant Operator.
Training in Safety and Hygiene.
Food Handling Training.
### **6\.** **SHE Requirements**
Theoretical and Practical Training in Emergency Plan
Fire Fighting Training: Use of extinguishers, fire hose stations (BIE), hydrants, SCBA
Training in use of Personal Protective Equipment specific to the job position
Risks and Preventive Measures related to forklifts
Manual handling of loads
Handling and storage of chemicals, CLP Regulation hygiene, labeling, MSDS and waste handling
Safety data sheets of handled products
DSM SHE Policy
LSR Life Saving Rules
Job position risks
Zone Classification training
Work permit procedure
Lockout procedure
Segregate and store generated waste.
Minimize to the maximum extent possible the potential impacts arising from activities.
Report to the Department Manager any potential environmental incidents/accidents, as well as critical situations that could lead to future environmental deficiencies.
### **7\.** **QA\&FS requirments**
Operation sheet management
Management of specifications for intermediate and final products
Food handler training
Application of HACCP standards
Quality System documentation management standards
Traceability/Recall
Halal Manual
PRPs: Infrastructure plan and layout of work areas
Utilities control: air, water, and energy
Waste disposal
Procurement and materials management
Measures to prevent cross contamination
Pest control
Rework
Warehouse management
Hygiene standards in changing rooms
Access to EDM
Kosher certifications
ISO 9001 and FSSC22000 certifications
Foreign body prevention
FSMA course
Customer commitments and Quality Policy
Final product labeling
Good documentation practices
Identification of sampling points affecting Quality

León, Spain

Indeed
Operario de producción DSP
**Overview:**
Execution of activities in Purification production department (Downstream), following operating procedures and GMP requisites.
Under supervision of Purification Supervisor and area technicians, performance of those specific\-department activities; equipment preparation and execution of standard producing procedures under cGMPs regulations, as a part of the work team.
Production operations associated to their department will include, among others, chromatographic resin and column handling, as well as direct and tangential filtration systems, intermediate product handling, excipients and solutions preparation, and equipment and material preparation.
**Responsibilities:**
* Execute Protein Purification activities in accordance with specifications from Research and Development department and quality standards of Company.
* Write Standard Operating Procedures (SOPs) corresponding to equipment and tasks of their department.
* Write Batch Records documents.
* Production equipment preparation prior to use as well as after use (cleaning, sanitization, etc.).
* Register all production activities in logbooks, batch records (BRs) or documentation according to guidelines and quality procedures of company.
* Preparation of media, buffers and process solutions, as well as filtration and/or sterilization.
* Support tasks of production material preparation, conditioning and sterilization.
* Participate in production equipment installation and qualification as well as provide support on its maintenance, calibration and requalification.
* Participate and propose improvements in production processes, records and Company activities, fostering continuous improvement within section.
* Follow production programs as well as formation and training.
* Provide information and support in research of quality deviations, as well as participate in implementation of follow\-up plans for corrective and preventive actions associated to each deviation.
* Interact with Suppliers of routine\-use equipment and items in production activities.
* Interact with the other company departments, always fostering friendly work environment.
* Modification and updates of Batch Records documents due to deviations, improvements or other reasons.
* Keep a respectful activity towards Environment complying with current Company regulations and requisites of safety, hygiene and environment.
* Participate in the work teams assigned to each customer, attending to meetings, teleconferences and other related activities.
**Qualifications:**
* Education: Professional Training medium or upper level. University degree is a plus.
* Languages: Fluent Spanish and basic\-intermediate English (B1\)
* Experience (years/area): \+1 years in lab or industrial processes
* Specific Knowledge: basic knowledge of unitary separation operations
* Travels: ocasionally
* Personal skills: Team player and willingness to learn.

C. 13, 26, 24192 León, Spain

Indeed
Manufacturing Technician I
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The Level I Production Operator (Technician I) learns and executes the aseptic batch manufacturing activities, billable activities or continuous improvement that are required in the production department, following the instructions and standard operating procedures in accordance with the AEMPS, FDA and other regulatory agencies under supervision. Ensuring the execution of production plans, while following all the company's safety guidelines.* Comply with manufacturing area safety regulations and work practices in accordance with all company Health, Safety and Environmental programs.
* Work as a team, being approachable, practical, motivating, able to support and inspire your co\-workers.
* Participation in the "Quarterly conversation"
* Comply with the schedule by following the prioritization instructions of their senior managers to ensure compliance with the schedules together with the department head.
* Collaborate in the identification of opportunities for continuous improvement to improve processes and practices.
* Comply with the requirements of cGMP, AEMPS, FDA and other regulatory agencies that have been implemented in the plant, as well as with the department's objectives and corporate quality standards.
* Collaborate and participate in preparing for inspections by regulatory agencies or clients.
* Participate in the control of the stock of plant consumables, to guarantee their availability.
* Collaborate in the investigations of the different quality events (deviations, CAPAs, change controls...).
* Inform the direct manager when anomalies are detected in the operation of equipment, as well as human errors, both their own and those of the team's personnel, in order to ensure the quality of the product manufactured.
* Inform the direct manager if safety equipment or human resources needs are identified.
* Collaborate in teamwork with other departments if required.
* Take care of and ensure the proper functioning of the equipment
* Operate production equipment following the guidelines indicated in the work procedures
* Participate in the manufacture of the different products following the indications of the Manufacturing Guides and complying with GMP regulations.
* Handle pallet trucks for the movement of goods.
* Demonstrate a general knowledge of aseptic techniques
* Successful participation in the gowning qualification as well as the Media Fill plan
* Review relevant SOPs and production lot records, as needed.
* Complete and maintain documentation related to assigned work, including notebooks, batch records, etc
* Comply with and maintain cleanliness and order of production areas in accordance with appropriate standard operating procedures.
* Perform the activities of dispensing and preparing materials to be used in the activities of the department.
* Perform the sanitization of materials prior to their introduction into the manufacturing areas
* Disinfect and clean production rooms
* Supports the activities of formulation processes
* Supports the activities of the activities of filtration processes
* Supports the activities of the processes of preparation of autoclave cycles and assembly of installations
* Supports the activities of the qualification of Production equipments.
* Operate production equipment following the guidelines indicated in the work procedures
* Perform cleaning of production equipment
* Supports the manufacture of the different products following the indications of the Manufacturing Guides and complying with GMP regulations.
* Supports the activities of SIP execution of sterilizable equipment
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
*PCI Pharma Services is an Equal* *Opportunity/Affirmative* *Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.**At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life\-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.*

C. de las Cien Doncellas, 2, 24003 León, Spain

Indeed
QA TECHNICIAN
Overview:
* Review and approval of the bulk batch records and related documents.
* Monitoring deviations/OOS/OOT reports raised on batches for approval.
* Review, maintain and approve all master batch records and its status on SAP system according to the marketing authorization.
* Evaluate and resolve all requirements/requests made by the customers (documentation request or information pertaining to product registration).
* Evaluate periodically bulk stock control to decide availability after holding time.
* Approve and/or reject batches of bulk products and intermediates in SAP system.
* Support to Customer requests based on QTA, Marketing Authorizations and/or Quality issues.
* Review and approved internal SOPs.
* Participation and support in internal audits, external audits and inspections according to the Annual Plan to assess the quality of the GMP system.
* Support to the qualified person and supervisor.
* Support and involvement on quality investigations.
* Suppport and involvement on Official GMP inspections and customer audits
* Management of GMP documentations and related archive.
* Train the new incorporations in the specific activities and functions of the position in which you are an expert.
Responsibilities:
Revision of master batch records and its validation/compliance on SAP system (BOM/Route). Manage GMP deviations relative to the process and site.
Review and approval manufactured batches.
Manage GMP deviations and OOS/OOT, previous to put them on the market.
Performed periodic stock control check; and manage of not conformities in accordance to internal procedures, GMPs rules, Authority and customers’ requirements and quality policy
Qualifications:
* **Education:** University Degree in Pharmacy, Chemistry, Biology or Sciences related to Health.
* **Languages:** Intermediate or high level of English and bilingual in Spanish.
* **Experience (years/area):** A minimum of 2 years’ experience in similar position.
* **Specific Knowledge:** Quality Assurance expertise and extensive knowledge on revision of GMP documentation. Knowledge on SAP/R3 and MS Office

Lugar Villasinta, 1007, 24193 Villasinta de Torío, León, Spain
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