Position Details
About this role
This role involves leading GMP compliance audits across manufacturing sites and partners, ensuring adherence to global pharmaceutical regulations, and maintaining high-quality standards.
Key Responsibilities
- Perform GMP audits
- Ensure regulatory compliance
- Manage audit reports
- Collaborate with manufacturing sites
- Maintain audit documentation
Technical Overview
The environment includes GMP audit processes, regulatory compliance standards, documentation management, and collaboration with manufacturing and quality teams.
Ideal Candidate
The ideal candidate is an experienced quality professional with at least 5 years of GMP audit and compliance experience within the pharmaceutical or biologics industry, capable of leading internal and external audits and ensuring regulatory adherence.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Certifications
Preferred
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of GMP audit experience, No familiarity with pharmaceutical regulations, No experience with GMP documentation, Less than 5 years of relevant experience
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