Executive / Sr. Executive – Quality Oversight (Contract Manufacturing)
1 week ago
Key Responsibilities
- Conduct preliminary review of:
- Batch Documentation
- Certificates of Analysis (CoAs)
- Change controls, deviations, and investigations
- Support preparation, review, and maintenance of:
- Specifications
- Test methods
- Master Manufacturing and Packaging Records
- Product artworks and labeling components
- Coordinate with contract manufacturing organizations (CMOs) for resolution of documentation queries and ensure timely turnaround.
- Assist in documentation for supplier qualification and product transfers.
- Maintain and update product master data in SAP, including:
- Material codes
- Specifications and test parameters
- Change control linkages
- Artwork version control
- Track and report progress on key quality actions and compliance metrics.
- Assist in preparing for regulatory and customer audits.
- Ensure proper documentation archiving, version control, and compliance with document retention policies.
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