For a client in Zaventem, I’m looking for a QP familiar with sterile environment and experience in managing priority and high workload.
- Eligible to act as a European Qualified Person under Belgium license.
- Certifying products in compliance with 2001/83/EC, 2003/94/EC and Annex 16.
- Supporting EU QP certification and release of both PGS and non PGS manufactured supplies.
The project serves to conduct EU QP batch certification and inventory release activities in accordance with EU GMP and the product marketing authorization. In addition, the QP will support those arrangements to alleviate drug shortage, including management of unlicensed supplies and exemptions provided by the BOH.
The QP will furthermore support the licensing requirements of the MIA (As identified and declared), including adherence, maintenance and development of the associated Quality Management System, continual professional development in associated dosage forms certified and BOH inspections and enquiries.
- Provides clear, direct and timely verbal and written communication to stakeholders.
- Able to plan, manage and communicate personal workload, prioritizing activities to support patient safety, compliance, business needs and continuity of supply. Able to perform functions with minimal direction from management.
- Contributes to resolving Quality & Operational issues across the business and site without direction.
- Able to function proactively within the business unit, working as a team player across a range of colleagues with a range knowledge and skill sets.
- Execute and manage projects, as per role assignment. Clear starter-finisher, taking responsibility for own and team deliverables.
- Good knowledge of English and French.
- Willing to travel. You might visit manufacturing sites (via taxi), possibly in another country.
- Location: Zaventem
- Start date: ASAP. At the end of March at the latest.
- Duration: >6 months
- Full time
Ulrike De Smedt
+32 15 858 034