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Quality Assurance Specialist
vor 2 Monaten
Job Description:
An exciting new opportunity has arisen to join Randstad as a Quality Assurance Specialist for our Biotech drug substance plant.
As an integral member of the Quality Unit, you will provide QA expertise for Process Validation and Analytical Validation:
- You will develop and implement qualification/validation strategies, review and approval of protocols and reports, participate in risk analysis, identify gaps and develop remediation plans.
- You will act 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 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.
Key Responsibilities:
- You will have a university degree with at least 5 years of experience in pharmaceutical quality environment.
- You will have proven experience in analytical methods validation and manufacturing process validation.
- You will have strong communication and team spirit skills.
- You will have good stress resistance.
- You will be fluent in French and English (oral and written).
