Deputy Manager- Quality Assurance- PR&D

·       Ensuring the compliance in Quality control laboratory w.r.t. SOP’s and regulatory requirements.

·       Imparting training to QC Associates on SOP’s and current regulatory requirements based on the review observations.

·       Review of Analytical data such as Finished, Intermediate, Raw material and Stability.

·       Review of electronic data and sequence audit trail against hard copy to ensure the accuracy of the analytical data.

·       Review of Stability Protocols, Stability schedules and Stability data sheets.

·       Review of master list of instruments, equipment’s and Qualification document.

·        Review of Preventive maintenance schedules, Calibration schedules and Calibration data of all Analytical Instruments in Quality control laboratory.

·       Review of Method transfer/Method verification/Method validation protocols and Reports including Raw Data.

·       Review of Reference Standards/Working Standards, data including Certificate of Analysis.

·       Preparation of quality comparison sheets for all dispatched material to ensure the analytical trend.

·       Review of monthly comphrensive assement reports, laboratory errors and invalidation.

·       Review of Analyst Qualification raw data.

·       Audit trial review of all the standalone instruments and Empower in Quality control department.

Review of certificate of analysis.