Qualified Person
Functieomschrijving
- Batch release & certification of APIs, excipients, primary packaging, bulk products (tablets & injectables), and final packaged products.
- Market complaint handling.
- Managing deviations, investigations, CAPAs, recalls, change controls, retests, rework/reprocess, and approval of PQRs/LQRs.
- Interacting daily with production teams on the shopfloor (no makeup/jewelry allowed in production areas).
- Reviewing and approving procedures in the QP activity scope.
- Supporting internal audits, client audits, and inspections.
- Ensuring products meet GMP standards and regulatory/MA dossier requirements.
- Being reactive to production needs while also having the authority to block batches when needed.
Profiel
- Ideally 5 years relevant experience
- Belgian Qualified Person (QP) number – mandatory and non-negotiable.
- Industrial pharmacist degree.
- Operational mindset: enjoys being on the shopfloor and reacting swiftly to production realities.
- Strong French communication skills (native or fully fluent) good English for interactions with global teams.
- Ability to work under pressure and remain supportive yet firm, especially when blocking non-compliant batches.
- Strong team spirit, collaborative attitude, ease of contact with multiple departments.
- Willingness to learn, follow procedures, apply GMP, and avoid taking risks beyond their level of expertise.
Nice to have: - Previous experience in GMP/QP activities, QA, Production or QC.
- Experience in packaging operations.
- A personality that adapts well, avoids conflict, and fits a collaborative culture.
Aanbod
- Bedrijfswagen