Job content

Key responsibilities

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

• Administrative release

• 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.

Candidate profile

Diploma: Pharmacist or other scientific Master

Preferred knowledge and skills:

• QA experience

• Pharmaceutical law

• 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)