Manager - Quality - Microbiology

1 week ago

Mumbai, Maharashtra, India Piramal Pharma Limited Full time ₹ 15,00,000 - ₹ 25,00,000 per year
  • Review any microbial data generated in the microbiology
  • Review microbiological and analytical data generated in labs, including entries in Open-Lab, lab notebooks, LIMS, and QMS modules.
  • Ensure accuracy and completeness in the review and generation of reports.
  • Prepare and review OOS, OOT, and lab incident investigations, ensuring thorough analysis and initiation of change controls.
  • Review planned and unplanned deviations for accuracy, completeness, and compliance with cGMP, data integrity, and written procedures.
  • Review protocols, reports, and Annual Product Quality Reviews (APQR).
  • Collaborate with site teams to identify and address gaps during QMS event reviews and documentation.
  • Coordinate with sites for review activities and planning to ensure efficient workflows.
  • Engage with customers and site teams to ensure timely closure of critical QMS events.
  • Share review deficiencies with site teams for corrective actions.
  • Route documents through the Ensur application (or other relevant platforms) across plants.
  • Participate in customer audits and regulatory inspections, providing support to site teams.
  • Lead and participate in additional tasks or projects as assigned by the Head of Department (HOD).

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    5 days ago

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