Executive / Senior Executive- CQA

7 days ago

North Goa Goa India, Goa 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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