Position Details
About this role
This role involves leading site self-inspections, managing CAPA processes, and ensuring compliance with pharmaceutical GMP standards and global regulations.
Key Responsibilities
- Create and track self-inspection plans
- Lead site inspections
- Evaluate CAPA items
- Ensure GMP compliance
- Participate in global audits
Technical Overview
Focus on pharmaceutical quality systems, GMP/cGMP standards, regulatory audits, and inspection readiness, with extensive experience in pharmaceutical quality assurance.
Ideal Candidate
The ideal candidate is a senior quality assurance professional with over 10 years of experience in pharmaceutical GMP environments, capable of leading self-inspections, audits, and ensuring compliance with global regulations.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Less than 10 years of GMP experience, Lack of experience with regulatory audits, No knowledge of cGMP or GMP standards
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