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.
Ensure regulatory compliance and quality in GMP processes, acting as QA and Compliance Manager and as backup for the API QA Technician. 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).
Supervise the investigation of OOS/OOT, ensuring immediate action, root cause analysis and action plan.
Document management system and quality assurance (API technical backup):
Prepare, review and control versions of SOPs, technical instructions, spreadsheets and GMP forms.
Participate in customer complaint investigations, ensuring feedback to the quality system.
Develop and control quality indicators and participate in management reviews.
Assess potential impacts on quality and safety, validate regulatory compliance, and document execution and closure.
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.
Maintain up-to-date records of supplier approval and monitoring.
Quality management system monitoring:
Participate in continuous improvement projects.
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.
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.
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).
com in English where possible
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.