Manager Quality Control

Job Description

Role & responsibilities Developing and Implementing QC Procedures: Creating and updating standard operating procedures (SOPs), specifications, and testing methods to ensure consistent quality. Analysis of Samples: Performing analytical testing on raw materials, in-process samples, intermediates, and finished products using techniques like HPLC, GC, and other relevant methods. Ensuring Compliance: Guaranteeing adherence to cGMP, GLP, and other regulatory guidelines, including documentation requirements. Investigating Deviations: Identifying and investigating out-of-specification results, incidents, and deviations, and initiating corrective and preventative actions (CAPA). Method Development and Validation: Developing and validating analytical methods for new or existing APIs and ensuring their suitability for quality control purposes. Equipment Qualification: Participating in the qualification of analytical instruments and equipment to ensure they are suitable for their intended use. Documentation: Maintaining accurate and up-to-date records of all quality control activities, including analysis reports, calibration records, and deviation investigations. Training: Providing training to other QC personnel on analytical techniques, procedures, and regulatory requirements. Collaboration: Working closely with other departments, such as production, R&D, and regulatory affairs, to ensure quality throughout the API lifecycle. Continuous Improvement: Participating in continuous improvement initiatives to enhance the efficiency and effectiveness of the QC processes. Preferred candidate profile