Quality Assurance Specialist
Vor 6 Tagen
We are seeking a highly skilled Quality Assurance Specialist to join our team at Randstad. As a key member of our Quality Unit, you will provide QA expertise for Process Validation and Analytical Validation.
- You will develop and implement qualification/validation strategies, review and approve protocols and reports, participate in risk analysis, and identify gaps and develop remediation plans.
- You will serve as a Quality Subject Matter Expert on specific topics and participate in risk assessments and handle deviations on these topics.
- You will review and/or approve qualification/validation documents, risk assessments, SOPs, and take quality decisions according to company standards.
The activities of the QA Specialist will cover all qualification/validation phases from Basic Design until 1st use of equipment/raw material. You will ensure GMP compliance during all phases of qualification/validation.
Requirements- You have a university degree with at least 5 years of experience in pharmaceutical quality environment.
- Proven experience in analytical methods validation and manufacturing process validation.
- Strong communication and team spirit.
- Good stress resistance.
- Fluent in French and English (oral & written).
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