PbAbout Us: /b /ppAs a global life science company, taking care of human, animal and plant life has been our priority for 50 years. Today, we are a world leader in the production of heparin – the primary anticoagulant used to save approximately 100 million lives every year. We have also set the benchmark for the manufacture of APIs and functional ingredients for the pharmaceutical, nutraceutical, veterinary, animal nutrition and agricultural sectors. We work to innovate in human, animal, and plant health. /ppWe believe that partnership is the key to success and we support our partners across the healthcare, plant and animal health markets worldwide. /ppbr/ppbr/ppbAbout the Role: /b /ppEnsure regulatory compliance and quality in GMP processes, acting as QA and Compliance Manager and as backup for the API QA Technician. Ensure document traceability, correct management of deviations, CAPAs and changes, and provide support in audits, Regulatory Affairs and document release, minimising regulatory risks and ensuring compliance with international standards. /ppbr/ppbr/ppbResponsibilities: /b /ppbr/ppReview of GMP documentation (API technical backup): /pulliReview and approve production spreadsheets, records and controls in accordance with GMP and PNT. /liliVerify the integrity, traceability and accuracy of critical data (processes, in-process controls, times, equipment). /liliParticipate in the documentary release of batches for evaluation prior to QP certification. /li /ulpManagement of deviations, CAPAs and OOS/OOT (technical API backup): /pulliCoordinate the investigation, closure and verification of deviations and non-conformities. /liliSupervise the investigation of OOS/OOT, ensuring immediate action, root cause analysis and action plan. /liliFollow up and verify corrective and preventive actions (CAPA). /li /ulpDocument management system and quality assurance (API technical backup): /pulliPrepare, review and control versions of SOPs, technical instructions, spreadsheets and GMP forms. /liliKeep the document management system up to date in accordance with ICH Q7 and applicable regulations. /liliParticipate in customer complaint investigations, ensuring feedback to the quality system. /liliDevelop and control quality indicators and participate in management reviews. /li /ulpChange management: /pulliCoordinate the change management process on the MasterControl platform. /liliAssess potential impacts on quality and safety, validate regulatory compliance, and document execution and closure. /li /ulpCompliance and Regulatory Affairs: /pulliPrepare and maintain documentation to be provided by QA for regulatory dossiers, site master files, certificates and documentation for authorities. /liliEnsure compliance with legal requirements for labelling and records. /liliProvide support in regulatory audits and inspections (EMA, FDA, AEMPS). /liliCoordinate with Regulatory Affairs for regulatory updates and communication with authorities. /li /ulpSupplier and Material Qualification: /pulliCollaborate in the evaluation and approval of raw materials, critical services and auxiliary materials. /liliMaintain up-to-date records of supplier approval and monitoring. /li /ulpAudits and Inspections: /pulliParticipate in internal, customer and authority audits. /liliPrepare evidence, records and corrective action plans. /liliAct as an internal auditor if trained. /li /ulpQuality management system monitoring: /pulliPrepare APR/PQR reports and management reviews. /liliParticipate in continuous improvement projects. /liliBe the point of contact for customer enquiries and approvals. /liliCoordinate with purchasing and the QA Supplier Manager to ensure supply reliability. /li /ulpQuality training and culture: /pulliProvide GMP training during onboarding and periodic training sessions. /liliPromote a culture of quality through awareness-raising activities. /li /ulpResponsibility in the integrated management system: /pulliBe familiar with and apply current regulations on safety, health, occupational risk prevention, quality, the environment and energy efficiency, and ensure compliance with them. /liliReport any risk situation in accordance with incident/accident management and quality event management procedures. /li /ulpbr/ppbAbout You: /b /ppbr/pulliDegree in Pharmacy, Chemistry, Biotechnology or similar. /liliSolid knowledge of GMP, ICH Q7, ISO and applicable regulations. /liliTraining in Compliance and Regulatory Affairs is desirable. /liliInternal Auditor certification in GMP, GLP, GDP, Quality Management Systems (food, feed) is desirable. /liliMinimum 2 years in QA and Compliance in GMP environments (pharmaceutical, API, chemical). /liliExperience in document management, audits, deviations and CAPAs. /liliExperience in Regulatory Affairs and supplier management is desirable. /liliKnowledge of the EU, FDA and EAEU regulatory environment and specific international regulations in destination countries. /li /ulpbr/ppbWhat’s Next: /b /ppIf this sounds like a role that you would be interested in, then we would love to hear from you. Apply with a copy of your CV at the link below. /pp*Please apply with your CV to in English where possible /ppWe value the support recruitment agencies provide, however we are unable to accept speculative CV’s from agencies we are not already engaged with. /ppbr/ppbClosing Date: /b 5th January 2026 /pp*Please note, closing dates are subject to change and, at time of high volume of applications, this may be brought forward. /ppbr/ppbOther important information: /b /ppEquality and diversity at Bioiberica: /ppWe value diversity and are committed to an inclusive working environment in which all employees are respected and supported regardless of gender, age, ethnic origin, religion, sexual orientation, disability, or social background. We expressly welcome applications from people with a wide range of perspectives and experiences. Our goal is to ensure equal opportunities and actively combat discrimination – both in the application process and in everyday working life. /p