For a client in the region of Zaventem, we are now looking for a Quality Manager (50%).
- available for the next six months?
- willing to work 50%?
- experienced in the processes of a pharma production environment?
- fluent in Dutch/English/French?
Then this project might be the next highlight on your resume!
Management roles & responsibilities
- Ensure that (new) regulations are implemented in the company
- All compliance issues including local quality systems in GMP and GDP and Regulatory matters (authorizations, supply…).
- To ensure the quality aspects through participation in cross-organisational projects, reporting systems and meetings (product maintenance, change controls, deviations, complaints, recall, …)
- QA function with respect to external suppliers and partners directly connected to the manufacturing site (e.g. qualification, audits, quality agreements, evaluation)
- To promote a good knowledge level in the QA area by setting up a training program for the Quality Unit personnel
Functional roles & 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 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.
- Reporting to the Global Operation Quality: Monthly reporting, inputs to annual report KPIs and Product recall reports.
- QA function with respect to external suppliers such as qualification, audits, and quality agreements.
- Provide help for the establishment of Quality Agreement with the partners.
- Act as an expert in quality processes tracked in EQMS.
- Participate in the periodic review of the Quality Manual.
- Maintain his/her knowledge level by suitable training:
- Participate in initial and continued training and qualification activities as required for the job function
- Complete training within the specified timeframe
- Complete all required training prior to performing assigned regulated job activities and work under supervision until qualified to work independently
- Document completed training per local requirements
- Seek clarification as needed to ensure understanding of job requirements and applicability of training completed
- Demonstrate knowledge or skills gained from completion of required training and qualification
- Participate in retraining when there is a knowledge or skill gap and when required refresher training is offered
Education and on the job experience
Min. 3 years of experience as Quality Assurance Officer or Manager
Spoken: Dutch, French, English (fluently)
Written: Dutch, French, English (fluently)
PC skills Easiness to work with digital platforms
Specific and current knowledge of international rules and guidelines for the pharmaceutical industry, Quality Management Systems, GMP & GDP and Regulatory Affairs.
Functional and process related knowledge, skills and abilities
- Experience in a pharmaceutical environment is required
- Autonomous and assume responsibilities
- Analytical mind
- Decision making based on scientific aspect and risk evaluation