QA Consultant Job in Brabant-Walloon 1300, Walloon-Brabant Belgium
Job description
For a pharmaceutical partner in Brabant-Wallon we are looking for a QA Consultant. He or she will provide QA support and oversight to major projects/validation activities according to ASTM E2500 approach.
Responsibilities
o Provide a compliance expertise in all major projects
o Ensure QA oversight of GTS Facility project from QRA/URS up to PQ
o Review / Approve the validation documentation regarding the GMP requirements and the procedures
- URB
- Basic Design
- Detail Design
- Design Review
- Validation master plan
- SOP
o Ensure the compliance in all Commissioning Qualification / Validation activities
o Attend all projects meetings as QA expert
o Ensure timely escalation to Mgt of critical issues during validation and / or projects
o Evaluate and approve change control
o Review and approve the potential CAPA plan issued from deviation or inspection
o Contribute auditing potential suppliers
o Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
Required Profile
o University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
o 2-5 years of experience in Validation and QA in a biopharmaceutical industry
o Process Control and CSV Validation knowledge would be considered an added value
o Good interpersonal relationship skills
o Good oral and written communication skills in French English
o Problem solving and achievement oriented
Pauwels Consulting Gent - Woodrow Wilsonplein 16 - B-9000 Gent - Tel 09 324 70 80
Pauwels Consulting Brussel - Lambroekstraat 5 - B-1831 Diegem - Tel: 02 719 04 50