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Amneal Pharmaceuticals LLC is seeking a senior quality control leader responsible for in-process and finished product QC analyses, ensuring compliance with GMP/GLP and regulatory standards. The role involves interpreting results, identifying trends, auditing processes, and guiding the QC team to prevent risks and drive continuous improvement.
You will lead investigations of deviations, review COA documentation, and support internal and external audits, with a focus on maintaining product quality
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.
Education: M. Sc. - Required /M. Pharm - Preferred
Experience: 10 to 15 Years