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.,
As a Validation Specialist, your role involves preparing and reviewing protocols for various validation activities such as Process, Method, Cleaning, Computer System Validation, and Stability Protocol. You will also be responsible for Calibration and Qualification, Risk Assessment, and ensuring compliance with the timetable for all equipment validation from internal and external sources. Your duties will include periodic updating of the validation master plan and reviewing risk assessment reports for manufacturing site activities. Additionally, reviewing the Master Validation plan is also part of your responsibilities. Key Responsibilities: - Prepare and review validation protocols for Process, Method, Cleaning, Computer System Validation, and Stability Protocol - Conduct Calibration and Qualification activities - Perform Risk Assessment - Generate reports for Qualification and Validation - Ensure compliance with validation timetables for all equipment - Update the validation master plan periodically - Review risk assessment reports for manufacturing site activities - Review the Master Validation plan Qualifications Required: - Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences) - Proven experience in validation activities - Knowledge of regulatory requirements and guidelines related to validation - Strong attention to detail and analytical skills Please note that the job description provided does not contain any additional details about the company.,