Job Title

Experience -8 to 10 years Qualification - M.Sc. (Chemistry)RESPONSIBILITIESReview cleaning validation, method transfer, method verification and method validation protocol, equipment qualification documents and provide recommendation for improvements. Review the QC lab /Analytical lab at all Unichem locations and confirm their compliance with GLP. Perform vendor audits, contract testing lab audits, other service provider audits as per annual audit planner and when required. Execute internal audits at all Unichem manufacturing location and corporate departments as per the Annual planner. Prepare and issue CQA guidelines to all sites and maintain all CQA documentation in line with good documentation practices. Review corporate SOP’s and provide recommendations for improvement. Review vendor qualification documents including vendor questionnaires and interact with the related departments to ensure documentation is completed as per the requirements. Perform elemental impurity risk assessments for Unichem Locations. Review change controls, out of specification, out of trend, deviations and other quality system investigation provided by Unichem locations, QC/ Analytical departments. Review various deliverables of computerized system validation received from Unichem locations of corporate departments. Perform and review element impurity and Nitrosamine impurity risk assessment at various Unichem locations. Perform any other related activity as instructed by Head CQA.DESIRED SKILLSMust have knowledge of compliance and GMP related requirements. Must have exposure to regulatory audits like USFDA, MHRA, EU and other related inspection is must. Should be organized and detail-oriented, with strong time management abilities. Excellent oral and written communication skills. Should demonstrate a high sense of responsibility, self-motivation, and teamwork while effectively planning and executing tasks independently.