To prepare and review the protocol for all Validation (Process, Method, Cleaning, Computer System Validation and Stability Protocol) Calibration and Qualification, Risk Assessment To prepare and review reports for Qualification and Validation. To ensure compliance with the time table for Qualification and Validation of all equipment, both internal and external sources. Periodic updation of validation master plan. To review risk assessment report for activities at the manufacturing site. Review Master Validation plan Show more Show less
Evaluate market complaint and initiate investigation. Identification of route cause (RCA). Investigate & Review OOS/OOT/CAPA . Review and ensure compliance for CAPA for both internal and external audits. To issue deviation & ensure, CAPA & RCA analysis for deviation. To provide RPN Numbers to Risk & plan CAPA as per RPN numbers as per SOP. Periodic Post Approval Review of Vendors (RM & PM) Issuance of STOP Sale Letters based on Stability Reports or Market Complaints Perform periodic mock recall inline with SOP Issuance of Response of Market Complaint to regulators / complainant Review of Fninished Product Specifications Compilation of Data for Skip Testing
You will be responsible for preparing and reviewing protocols for various validation activities such as Process, Method, Cleaning, Computer System, and Stability Protocols. You will also be involved in Calibration and Qualification, as well as Risk Assessment processes. Your duties will include preparing and reviewing reports related to Qualification and Validation. It is essential to ensure that all equipment, whether from internal or external sources, undergoes Qualification and Validation within the specified timetable to maintain compliance. You will be required to periodically update the validation master plan and review risk assessment reports for activities conducted at the manufacturing site. Additionally, reviewing the Master Validation plan will be part of your responsibilities.,