Executive / Senior Executive- CQA

Experience -

Qualification - M

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.