Draft and maintain the quality system, handle complaints, perform audits, draft technical agreements, check analysis certificates in order to ensure the quality of the products on the market. Manage the local QA team (3 persons).
Maintain the Quality Management System of the company:
Implement, monitor, maintain the system
Perform internal and external audits
Draft and follow-up of the self-inspection plan
Write, evaluate and communicate new procedures and work instructions
Responsible for all product recalls
Follow-up and execute preventive and corrective actions
Act as contact person for the Corporate QA and other external stakeholders
Ensure the quality and conformity of the products:
Manage and follow-up of the qualified person responsible for the release of our medicines
Evaluation of quality problems and deviations during production, packaging and / or analysis in cooperation with the QA team
Review of vendor qualifications
Obtaining import and / or export licenses for psychotropic medicines.
Handling of QA complaints
PQR’s, quality agreements and stability issues:
Ensure interface with Local Pharmacovigilance Officer for identification of adverse reactions / ADRs from product complaints and vice-versa.
Approve Quality agreements with the manufacturers
Approval of the Product Quality Reviews (PQR) drawn up by the QA officer (both the PQRs of the manufacturers and internal PQRs)
Follow-up of the Stability issues reported by manufacturers and corporate QA, checking the reports prepared by the QA compliance officer.
Diploma: Pharmacist or other scientific Master
Preferred knowledge and skills:
Languages: Dutch, French and English
PC skills: Word, Excel, Adobe, Outlook
Very accurate and correct
A real MEP (Motivation, Energy and Passion for the job)