Quality Assurance Specialist
vor 2 Monaten
We are seeking a highly skilled Quality Assurance Specialist to join our team at WuXi AppTec. As a key member of our Quality Operations team, you will be responsible for ensuring the quality and compliance of our products and processes.
Key Responsibilities- Support the design of Master Batch Records for bulk or packaged commercial drug products.
- Review and approve executed batch records and associated QA samples.
- Ensure compilation and archiving of documentation for compliance to GMP.
- Handle deviations, complaints, and CAPA related to Couvet site.
- Collaborate with partners on GMP activities.
- Develop and maintain SOPs and quality documents for Quality department.
- Support qualification and validation documentation for QA review.
- Represent QA within department and cross-functional project teams.
- BS in science or relevant discipline.
- At least 1-2 years Quality Control and/or Quality Assurance experience in a pharmaceutical company or related industry.
- Good understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
- Excellent interpersonal, collaborative, and organizational skills.
- Strong written and oral communication skills in both French and English.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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Quality Assurance Specialist
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