QA Validation Oversight

For one of our clients in the pharmaceutical industry, we are currentlylooking for a QA Validation Oversight

Start: 1/7/13
End: 31/12/13
Location: South of Brussels

MISSION DESCRIPTION:

Mission Purpose:

- Provide QA support and oversight to major projects/validation activities according to the clients validation procedures

Key Responsibilities

- Provide a compliance expertise in all major projects
- Ensure QA oversight in all validation activities
- Review/Approve the validation documentation regarding the GMPrequirements and the clients procedures
- Attend all project meetings as QA expert
- Ensure timely escalation to Mgt of critical issues during validationand/or projects
- Ensure regulatory inspection readiness for all validation topics
- Contribute to perform L2 audits for validation topics
- Approve/Review change control (linked to project/validation)
- Contribute to the deviation process providing QA oversight andapproving deviation for: deviations related to validation activitiesand/or impact of manufacturing deviations to validation activities
- 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.