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.