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Description:
The role is responsible for ensuring in-process and final product quality analyses in compliance with regulatory standards and internal specifications. The role focuses on interpreting and evaluating analytical results for accuracy and precision against established criteria. The role involves identifying recurring quality issues, preventing potential production risks, and recommending continuous improvement actions. The position uses validated testing equipment, measuring devices, and prescribed methods to accept or reject materials and products. As a people leader, the role audits and monitors manufacturing processes, oversees random testing of finished goods,
and ensures timely reporting of deviations and defects to maintain product quality and compliance.
Essential Functions:
- Oversee in-process and finished product quality control testing activities
- Interpret analytical results against approved specifications and standards
- Identify quality trends, deviations, and potential production risks
- Ensure acceptance or rejection of materials and products based on test results
- Audit and monitor manufacturing processes for quality compliance
- Review and approve analytical data, reports, and COA documentation
- Lead investigation of deviations, defects, and non-conformances
- Ensure compliance with GMP, GLP, and regulatory requirements
- Manage and develop QC team performance and competency
- Support internal and external audits and regulatory inspections
- Drive continuous improvement initiatives within QC operations
- Build team capability through Training and Competency Management
Additional Responsibilities:
Education: M. Sc. - Required /M. Pharm - Preferred