Description
For one of our clients in the pharmaceutical industry, we are currently looking for a QA Project Supervisor
Start:ASAP
Length:3 months
Location:South of Brussels
Mission Purpose:
- Provide QA support and oversight to major projects/validationactivities according to ASTM E2500 approach
Key Responsibilities:
- Provide a compliance expertise in all major projects
- Ensure QA oversight of Eng Facility project from QRA/URS up to PQ
- Review/Approve the validation documentation regarding the GMPrequirements and the procedures: URB - Basic Design - Detail Design- Design Review, Validation master plan, SOP, .to Validationreport
- Ensure the compliance in allCommissioning&Qualification/Validation activities
- Attend all projects meetings as QA expert
- Ensure timely escalation to Mgt of critical issues during validationand/or projects
- Evaluate and approve change control
- Review and approve the potential CAPA plan issued from deviation orinspection
- Contribute auditing potential suppliers
- Pro-actively identify potential quality and compliance risks andmanage these risks through the risk register and quality plan process
- Work in autonomy with supervision/coaching
Education:
- University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
Knowledge:
- Good interpersonal relationship skills
- Good oral and written communication skills in French & English
- Problem solving and achievement oriented
Previous Experience:
- 2-5 years of experience in Validation and QA in a biopharmaceuticalindustry.
(Process Control and CSV Validation knowledge would be considered anadded value).