Assistant Manager - Quality Control Department
Current• Ensuring strict adherence to Current Good Manufacturing Practice (cGMP) and Current Good Laboratory Practice (cGLP) to maintain high product quality• Reviewing and maintaining the integrity of quality records• Executing thorough investigation of Out of Specification (OOS), Out of Trend (OOT), and incidents, ensuring the implementation of appropriate Corrective and Preventive Actions (CAPA) when required• Reviewing and updating Standard Operating Procedures (SOPs), general analytical methods, and finished product specifications regularly to ensure best practices• Conducting a meticulous review of analytical batch records, ensuring accurate calculations and final reported results• Ensuring the completion and verification of each batch's documents, annexures, and checklists• Managing work allocation within the team and ensuring timely completion of stability testing tasks• Playing a crucial role in Stability Management within Quality Control, including monitoring all stability-related activities and chambers• Regularly updating and reviewing Stability protocols, reports, and summaries to ensure adherence to standards• Coordinating with the maintenance department to qualification, validate, and calibrate measuring and testing equipment/instruments• Conduct audit trail reviews of batch data in chromatographic and non-chromatographic instruments• Managing customer complaints pertaining to product quality, ensuring timely resolution• Overseeing the handling of change control and deviations to ensure compliance• Identifying training needs in the department, providing training to personnel in quality control, ensuring timely communication of SOPs/STPs and specifications to relevant team members, and ensuring all relevant Instruments/Equipment were calibrated as per SOPs• Delegating responsibilities to Deputy Manager/Assistant Manager during my absence, ensuring uninterrupted operations
