Executive-Quality Control

The Executive - Quality Control (API) will be responsible for overseeing and ensuring the quality of active pharmaceutical ingredients (APIs) through various testing procedures and adherence to regulatory standards. This role involves supervising the QC team, conducting analytical tests, maintaining documentation, and ensuring compliance with GMP and regulatory requirements.

Roles and Responsibilities':

• Conduct and supervise analytical testing of raw materials, in-process samples, intermediates, and finished APIs using techniques such as HPLC, GC, FTIR, UV-Vis Spectroscopy, and other analytical methods.
• Review and approve analytical data to ensure compliance with specifications and regulatory standards.
• Perform stability testing for APIs and analyze results for batch release.
• Maintain accurate and detailed documentation for all quality control activities, including laboratory notebooks, test results, and certificates of analysis (CoAs).
• Ensure compliance with Good Manufacturing Practices (GMP), ISO standards, and regulatory guidelines (e. g. , FDA, EMA) during all QC operations.
• Assist in the preparation of Standard Operating Procedures (SOPs) and ensure adherence to them.
• Monitor and maintain laboratory equipment, ensuring calibration and validation are performed as required.
• Provide technical support and guidance to the QC team to troubleshoot issues and ensure smooth operations.
• Train and mentor junior staff on testing procedures, safety practices, and GMP compliance.
• Assist in preparing for and managing internal and external audits, ensuring that QC processes meet regulatory requirements.
• Address and resolve audit findings by implementing corrective and preventive actions (CAPAs).
• Collaborate with production, R&D, regulatory affairs, and other departments to resolve quality issues and optimize processes.
• Support the transfer of analytical methods from R&D to QC for validation and routine use.