Executive / Senior Executive- CQA

3 days ago

Panaji, India Unichem Laboratories Limited Full time

Experience - 8 to 10 years Qualification - M.Sc. (Chemistry) RESPONSIBILITIES - Review 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 SKILLS - Must 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.

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