Salamanca Web & Interaction Design Job Listings

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Spclst, Quality Systems & Compliance

Job Description Do you want to be part of a global pharmaceutical company that uses innovative science to save and improve the lives of people and animals around the world? This is your opportunity! At our Salamanca site, where we are dedicated to the production of animal health vaccines, we are currently seeking a specialist in quality systems and regulatory compliance. **Position Objective** To review and ensure that manufactured products released to the market comply with GMP regulations, our company's Quality Manual, and applicable regulatory requirements. This position will initially be located within the Quality Systems department, with responsibilities for Quality Supervision activities related to equipment qualifications, and responsibilities for conducting Validations (aseptic simulations, product/process validation, and cleaning validation) during the construction, qualification, and validation phase, transitioning to the Quality Assurance department at the start of commercial production activities. **Key Responsibilities** Initial Phase – Quality Systems: * Review documentation for facility and/or equipment qualifications. * Execution of validation activities (aseptic simulation, process/product validation, and cleaning validation). * Management of Events, CAPAs, and Change Controls (quality member) related to the P5 and P8 PCX vaccine manufacturing and packaging building project. Quality Assurance Phase: * Creation/review/approval of documentation related to Quality activities. * Management of Quality information. * Management of Events, CAPAs, and Change Controls (quality member). * Quality member in product complaints. * Support as QA representative in the introduction or transfer of new products. * Conduct Quality Oversight. * Creation and maintenance of Quality master data in SAP. * Specification management. * Participation in internal, regulatory, and corporate audits. **Requirements** * Degree in Health Sciences (preferably Pharmacy, Master’s in Pharmaceutical Industry) * Relevant professional experience in the pharmaceutical sector. * Advanced knowledge of English. * Knowledge of facility and/or equipment qualification and validation. * Advanced regulatory knowledge of Good Manufacturing Practices and applicable Pharmacopoeias. * Knowledge of Document Management Systems. * Advanced knowledge of Quality System tools (change controls, deviation management, out-of-specification results, CAPA management, validations, etc.). * Data management in SAP. * Experience in biological and sterile product manufacturing processes will be valued. * Experience in project participation, technology transfers, and audits will be valued. * Experience in risk management, statistical tools, and continuous improvement methodologies will be valued. **Required Skills:** Aseptic Manufacturing, Aseptic Manufacturing, Auditing, Batch Record Review, Bioprocess Engineering, Consulting, Corporate Productions, Corrective Action Management, Data Analysis, Data Quality Assurance, FDA Compliance, Good Manufacturing Practices (GMP), GxP Validation, Personal Initiative, Pharmaceutical Management, Pharmacology, Pharmacovigilance, Policy Development, Product Quality Assurance, Project Manufacturing, QA Leadership, Quality Assurance Processes, Quality Control (QC), Quality Improvement Programs, Quality Management {\+ 2 more}**Preferred Skills:** Current Employees apply HERE Current Contingent Workers apply HERE **Search Firm Representatives Please Read Carefully** Merck \& Co., Inc., Rahway, NJ, USA, also known as Merck Sharp \& Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre\-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular**Relocation:** **VISA Sponsorship:** **Travel Requirements:** **Flexible Work Arrangements:** Not Applicable**Shift:** **Valid Driving License:** **Hazardous Material(s):** **Job Posting End Date:** 10/23/2025* **A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:**R369130

Calle Arcediano, 2, 37008 Salamanca, Spain

Negotiable Salary