Position Details
About this role
This role involves ensuring compliance with GMP and FDA regulations at a pharmaceutical manufacturing site, supporting quality systems, and overseeing utilities, equipment, and documentation.
Key Responsibilities
- Ensure GMP compliance
- Support qualification strategies
- Monitor utilities and facilities
- Handle deviations and change controls
- Maintain documentation
Technical Overview
The position requires knowledge of GMP, 21 CFR Part 11, computerized system validation, utilities, equipment, and facilities management within a regulated environment.
Ideal Candidate
The ideal candidate is a mid-level quality assurance engineer with at least 3 years of experience in FDA regulated manufacturing environments, familiar with GMP, 21 CFR Part 11, and quality documentation processes.
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 experience in FDA regulated environment, No Bachelor's degree in Engineering, No knowledge of GMP or 21 CFR Part 11
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