Deputy Manager- Quality Assurance- PR&D

As a Quality Control Laboratory Compliance Specialist, your role will involve ensuring compliance with SOPs and regulatory requirements. You will be responsible for imparting training to QC Associates on SOPs and current regulatory requirements based on review observations. Your key responsibilities will include: - Reviewing analytical data for Finished, Intermediate, Raw materials, and Stability. - Ensuring the accuracy of analytical data by reviewing electronic data and sequence audit trail against hard copy. - Reviewing Stability Protocols, schedules, and data sheets. - Reviewing the master list of instruments, equipment, and Qualification documents. - Reviewing Preventive maintenance schedules, Calibration schedules, and Calibration data of all Analytical Instruments in the Quality control laboratory. - Reviewing Method transfer/Method verification/Method validation protocols and Reports, including Raw Data. - Reviewing Reference Standards/Working Standards data, including Certificate of Analysis. - Preparation of quality comparison sheets for all dispatched material to ensure analytical trend. - Reviewing monthly comprehensive assessment reports, laboratory errors, and invalidation. - Reviewing Analyst Qualification raw data. - Audit trail review of all standalone instruments and Empower in the Quality control department. In addition to the job responsibilities mentioned above, the company may require you to review the certificate of analysis.,