Palafolls \| 1 Vacancy Posted on 09 Dec 2025 General Information Ensure regulatory compliance and quality in GMP processes, acting as the Quality Assurance and Compliance responsible person and as backup for the API QA Technician. Guarantee document traceability, proper management of deviations, CAPAs, and changes, and provide support during audits, Regulatory Affairs activities, and document release—minimizing regulatory risks and ensuring conformity with international standards. About the Position**GMP Documentation Review (API Technician Backup)** * Review and approve production forms, records, and controls in accordance with GMP and PNT. * Verify integrity, traceability, and accuracy of critical data (processes, in-process controls, times, equipment). * Participate in document release of batches for pre-certification evaluation by the Qualified Person (QP). **Deviation, CAPA, and OOS/OOT Management (API Technician Backup)** * Coordinate investigation, closure, and verification of deviations and non-conformities. * Supervise OOS/OOT investigations, ensuring immediate actions, root cause analysis, and action plans. * Track and verify corrective and preventive actions (CAPA). **Document Management System and Quality Assurance (API Technician Backup)** * Draft, review, and control versions of SOPs, technical instructions, GMP forms, and templates. * Maintain the document management system updated according to ICH Q7 and applicable regulations. * Participate in customer complaint investigations, ensuring feedback into the quality system. * Develop and monitor quality indicators and participate in management reviews. **Change Management** * Coordinate the change management process within the MasterControl platform. * Assess potential impacts on quality and safety, validate regulatory compliance, and document implementation and closure. **Compliance and Regulatory Affairs** * Prepare and maintain documentation required by QA for regulatory dossiers, Site Master File, certificates, and submissions to authorities. * Ensure compliance with legal requirements regarding labeling and recordkeeping. * Support regulatory audits and inspections (EMA, FDA, AEMPS). * Coordinate with Regulatory Affairs on regulatory updates and communication with authorities. **Supplier and Material Qualification** * Collaborate in the evaluation and approval of raw materials, critical services, and auxiliary materials. * Maintain up-to-date qualification records and supplier performance tracking. **Audits and Inspections** * Participate in internal, customer, and regulatory audits. * Prepare evidence, records, and corrective action plans. * Act as an internal auditor if appropriately trained. **Quality Management System Monitoring** * Prepare APR/PQR reports and management reviews. * Participate in continuous improvement projects. * Serve as the point of contact for customer inquiries and qualifications. * Coordinate with Procurement and QA Supplier Manager to ensure supply reliability. **Training and Quality Culture** * Deliver GMP training during onboarding and periodic refresher sessions. * Promote quality culture through awareness-raising activities. **Responsibility in the Integrated Management System:** * Know and apply current standards for safety, health, occupational risk prevention, quality, environment, and energy efficiency—and ensure their implementation. * Report any risk situations per incident/accident management and quality event procedures. Requirements* Minimum 2 years’ experience in QA and Compliance within GMP environments (pharma, API, chemical). * Experience in document management, audits, deviations, and CAPAs. * Prior experience in Regulatory Affairs and supplier management is desirable. * Knowledge of EU, FDA, EAEU regulatory frameworks and specific international regulations applicable to destination countries. * Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, or related field. * Solid knowledge of GMP, ICH Q7, ISO standards, and applicable regulations. * Training in Compliance and Regulatory Affairs is advantageous. * Internal GMP, GLP, GDP, or quality management system (food/feed) auditor certification is advantageous. Equality and Diversity at Bioiberica*We value diversity and are committed to an inclusive workplace where all employees are respected and supported, regardless of gender, age, ethnic origin, religion, sexual orientation, disability, or socioeconomic background. We expressly welcome applications from individuals with a broad range of perspectives and experiences. Our goal is to ensure equal opportunities and actively combat discrimination both during recruitment and throughout daily working life.* **Are you interested in this opportunity?** ----------------------------- Complete the form and our team will contact you with all the information you need to make the best decision.