Position Details
About this role
This role involves overseeing quality records, conducting deviation investigations, and ensuring compliance with GxP and cGMP standards in biotech manufacturing facilities.
Key Responsibilities
- Conduct quality investigations
- Manage deviation and CAPA processes
- Ensure regulatory compliance
- Support validation activities
- Maintain inspection readiness
Technical Overview
The technical scope includes GxP quality systems, deviation management, CAPA processes, validation, and inspection readiness within biotech or pharmaceutical environments.
Ideal Candidate
The ideal candidate is an experienced QA specialist with a strong background in GxP compliance, deviation investigations, and validation within biotech or pharmaceutical manufacturing environments. Attention to detail and regulatory knowledge are critical.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience with GxP or cGMP, No background in biotech/pharmaceutical quality assurance, Unwillingness to work in regulated environments
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