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 the proper administrative management of the Quality Assurance (QA) area, ensuring compliance with GMP requirements and applicable regulations, through the organisation, control and archiving of critical documentation, support in audits and coordination with other areas.
Document management and record control: Control versions and ensure the correct distribution of current documents. File physical and digital documentation in compliance with traceability requirements. Keep the document management system (DMS) up to date. Support in quality processes: Record quality events in the system. Prepare periodic reports on quality indicators. Assist in the preparation of internal and external audits. Monitoring the product release process: Monitor the release status of batches to ensure on-time deliveries to customers. Act as the QA liaison with the areas involved in order tracking. Manage QA team schedules and meetings. Prepare minutes and reports of quality-related meetings. Coordinate data collection between departments (production, logistics, regulatory, etc.). Training and qualification control: Maintain staff training records in the document management system (MasterControl). Coordinate the scheduling of courses and internal assessments related to the Quality area (GMP/HACCP/HALAL/GMP+, etc.). Generate reports on compliance with mandatory training in MasterControl. Support for inspections and audits: Prepare documentation required by authorities and auditors. Provide logistical support during audits (reception, agenda, follow-up). Responsibility in the Integrated Management System: Know and apply current standards for safety, health, occupational risk prevention, quality, environment, energy efficiency, and ensure compliance. Communicate any risk situation in accordance with incident/accident management and quality event management procedures Solid knowledge of GMP regulations and quality management systems. Additional training in document management and compliance is desirable.
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