The Quality Assurance Specialist/Qualified Person (QP) proposes and implements actions to guarantee the quality of manufacturing and the service provided to customers. The QP ensures compliance with good manufacturing and distribution practices, and the continuous operations. The QP releases the batches of raw materials and finished products as well as the preparations made on the site.
1) QUALITY ASSURANCE:
- Develop and update the company’s Quality Assurance Manual,
- Define the company’s quality objectives,
- Define and apply the quality policy towards suppliers and subcontractors;
- Establish the annual assessment of product quality (incidents, deviations, non-conformities, anomalies, complaints, etc.), evaluate the adequacy of corrective actions and analyze trends,
- Propose improvements and developments in the field of quality;
- Record and formalize changes (specifications, tests, processes, equipment, etc.).
2) PHARMACEUTICAL AFFAIRS :
- Record, process and manage, according to the procedures in force, internal and external complaints relating to the quality of manufactured, subcontracted or purchased products;
- Provide support in the context of responses to the FAGG/AFMPS concerning discrepancies noted during inspections;
- Ensure all matters relating to Quality.
3) QUALITY DOCUMENTATION :
- Approve all quality documentation (procedures, operating methods and documents)
- Write or coordinate the writing and update the general procedures applicable to all sites;
- Coordinate the drafting of subcontracting specifications;
- Supervise the organization of quality document management.
4) AUDITS :
- Define the program and scope of internal and external audits (suppliers and subcontractors);
- Develop and validate the annual audit calendar;
- Validate the internal and external audit framework;
- Contribute to their realization;
- Participate in the evaluation.
We are looking for a candidate who has a Qualified Person certification.
We are open for young professionals.
French is a must.
Want to take this challenge?
Send your resume to roxane@nuwhi.be or to liske@nuwhi.be and tell us a little more about yourself. You will hear from us soon!
