Deputy Manager

10 hours ago

North Goa Goa India, Goa Unichem Laboratories Limited Full time

Experience - 10 to 16 years


Qualification - M.Sc. (Chemistry)


Responsibilities


  • Review change controls deviations and other quality system investigations across locations and send them for approval.
  • Review vendor qualification documents including vendor questionnaires and interact with the related departments to ensure documentation is completed as per the requirements.
  • Execute internal audits at all locations annually.
  • 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 process validations protocol and reports, stability protocols, MPR’s of manufacturing location and corporate departments and equipment qualification documents and provide recommendation for improvements.
  • Perform vendor audits as per annual audit planner or as and when required.
  • Perform elemental impurity risk assessments for Unichem Locations.
  • Approve change controls, deviations, validation protocol / reports and other quality system investigations etc. provided by locations in absence of Head CQA and DGM CQA
  • Perform any other related activity as instructed by Head CQA.


Desired Skills


  • Experience in QA related activities in a reputed pharmaceutical organization.
  • Should have excellent knowledge of CQA activities, vendor qualification internal audits, and external audits.
  • Exposure to regulatory audits like USFDA,MHRA,EU and other related inspection is must.
  • Good interpersonal, communication and problem-solving skills.
  • Should be assertive, proactive and self-driven.
  • Ability to work in a fast-paced, demanding, timeline-driven environment.

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