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gmp veeva cgmp master batch records 21 cfr part 210📋 Description
- Perform QA activities to ensure compliance with Revance procedures and regs.
- Coordinate area approvals and product inspections.
- Review SOPs, master batch records, and packaging/labeling records.
- Review batch records and deviations for disposition (internal/external).
- Perform retain sampling and maintain the reserve sample program.
- Update databases to report quarterly metrics.
🎯 Requirements
- Bachelor’s degree in biology, chemistry, or related science.
- 2+ years’ directly related QA experience.
- Experience in aseptic manufacturing processes.
- Knowledge of cGMP, 21 CFR Parts 210/211, Eudralex Volume 4, and ICH.
- Proficient with word processing, databases, and software.
- Ability to work cross-functionally.
🎁 Benefits
- Competitive compensation with base salary and annual bonus.
- Flexible PTO, holidays, and parental leave.
- Generous health benefits, HSA match, 401k match.
- Employer-paid life and disability insurance.
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