The companyOur client is a professional Pharmaceutical organisation, based in Brussels Hoofdstedelijk Gewest Belgium. Our client is a patient-focused, pharmaceutical company committed to bringing Health to people worldwide.
Role descriptionPROJECT 2-3 days per week for initially 6 months ---
In this role you will be responsible for the implementation of (new) regulations and ensuring compliancy. You will participate in cross-organisational projects, reporting systems and meetings (product maintenance, change controls, deviations, complaints, recall, …). Also you will be responsible for external QA - suppliers and partners directly connected to the manufacturing site (e.g. qualification, audits, quality agreements, evaluation). You promote a good knowledge level in the QA area by setting up a training program for the Quality Unit personnel.
Responsibilities• To prepare and review the documents linked to the implementation of the Quality Policy and the Quality Management System (SOPs, WI’s…).
• To implement correct written procedures, in conformity with the internal and international guidelines.
• To guarantee that a good documentation system is in place.
• Participates in the solving of different problems and support for corrective actions in the GxP areas.
• Organisation and performance of Quality Management Review.
• Organisation and performance of self-inspections in GxP relevant areas.
• QA function with respect to external suppliers such as qualification, audits and quality agreements.
Requirements• Education and on the job experience: Min. 3 years of experience as Quality Assurance Officer or Manager
• Language skills: English, Dutch and/or French
• Specific and current knowledge of international rules and guidelines for the pharmaceutical industry, Quality Management Systems, GMP & GDP and Regulatory Affairs.
• Experience in a pharmaceutical environment is required
• Autonomous and assume responsibilities
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.