Associate Specialist QA Operations
Vor 5 Tagen
Job Summary
WuXi AppTec is seeking a highly skilled Associate Specialist QA Operations to join our team. As a key member of our Quality Assurance 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.
- Support GMP activities in cooperation with partners.
- Write, revise, and recommend SOPs and quality documents.
- Handle qualification and validation documentation for QA review.
- Support during Authorities inspections and internal audits.
- Represent QA within department and cross-functional project teams.
Requirements
- BS in science or relevant discipline.
- At least 1-2 years Quality Control and/or Quality Assurance experience in a pharmaceutical company or other 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.
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