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.
