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About Us:As 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.We believe that partnership is the key to success and we support our partners across the healthcare, plant and animal health markets worldwide.About the Role:Ensure 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.Responsibilities:Review of GMP documentation (API technical backup):Review and approve production spreadsheets, records and controls in accordance with GMP and PNT.Verify the integrity, traceability and accuracy of critical data (processes, in-process controls, times, equipment).Participate in the documentary release of batches for evaluation prior to QP certification.Management of deviations, CAPAs and OOS/OOT (technical API backup):Coordinate the investigation, closure and verification of deviations and non-conformities.Supervise the investigation of OOS/OOT, ensuring immediate action, root cause analysis and action plan.Follow up and verify corrective and preventive actions (CAPA).Document management system and quality assurance (API technical backup):Prepare, review and control versions of SOPs, technical instructions, spreadsheets and GMP forms.Keep the document management system up to date in accordance with ICH Q7 and applicable regulations.Participate in customer complaint investigations, ensuring feedback to the quality system.Develop and control quality indicators and participate in management reviews.Change management:- Coordinate the change management process on the MasterControl platform.¿Todo listo para enviar su solicitud? Asegúrese de comprender todas las responsabilidades y tareas asociadas a este puesto antes de continuar.- Assess potential impacts on quality and safety, validate regulatory compliance, and document execution and closure.Compliance and Regulatory Affairs:Prepare and maintain documentation to be provided by QA for regulatory dossiers, site master files, certificates and documentation for authorities.Ensure compliance with legal requirements for labelling and records.Provide support in regulatory audits and inspections (EMA, FDA, AEMPS).Coordinate with Regulatory Affairs for 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 records of supplier approval and monitoring.Audits and Inspections:Participate in internal, customer and authority audits.Prepare evidence, records and corrective action plans.Act as an internal auditor if trained.Quality management system monitoring:Prepare APR/PQR reports and management reviews.Participate in continuous improvement projects.Be the point of contact for customer enquiries and approvals.Coordinate with purchasing and the QA Supplier Manager to ensure supply reliability.Quality training and culture:- Provide GMP training during onboarding and periodic training sessions.- Promote a culture of quality through awareness-raising activities.Responsibility in the integrated management system:- Be familiar with and apply current regulations on safety, health, occupational risk prevention, quality, the environment and energy efficiency, and ensure compliance with them.- Report any risk situation in accordance with incident/accident management and quality event management procedures.About You:Degree in Pharmacy, Chemistry, Biotechnology or similar.Solid knowledge of GMP, ICH Q7, ISO and applicable regulations.Training in Compliance and Regulatory Affairs is desirable.Internal Auditor certification in GMP, GLP, GDP, Quality Management Systems (food, feed) is desirable.Minimum 2 years in QA and Compliance in GMP environments (pharmaceutical, API, chemical).Experience in document management, audits, deviations and CAPAs.Experience in Regulatory Affairs and supplier management is desirable.Knowledge of the EU, FDA and EAEU regulatory environment and specific international regulations in destination countries.What's Next:If 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.*Please apply with your CV to in English where possibleWe value the support recruitment agencies provide, however we are unable to accept speculative CV's from agencies we are not already engaged with.Closing Date: 5th January 2026*Please note, closing dates are subject to change and, at time of high volume of applications, this may be brought forward.Other important information:Equality and diversity at Bioiberica:We 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. xsgfvud Our goal is to ensure equal opportunities and actively combat discrimination – both in the application process and in everyday working life.
