AM/ Dy Manager- Packaging

3 weeks ago

Mumbai, India Unichem Laboratories Full time

Responsibilities

  • Review quality documents prepared by Packaging department which includes material specification, instructions and MPCR II before issuing to plant.
  • Ensure and review change control, deviations, CAPA, logs & database.
  • Prepare training calendar, provide periodic training & monitor any revisions to packaging SOP and applicable CQA Guidelines.
  • Implementation of DMS systems.
  • Ensure compliance with respect to yearly departmental audit by CQA and submit compliance report.
  • Validation of software and equipment for packaging development.
  • Conduct monthly meetings with all Unichem sites for packaging deliverables & coordinate with plant teams for the approval and release of documentation as per plant requirement.
  • Handle computer validation systems for packaging development related software.
  • Audit the packaging material vendor for cGMP compliance.
  • Create timeline tracker along with a workplan of packaging deliverables. Create Master Data sheet for all documentation.
  • Assign monthly document changeovers to team members & ensuring the reconciliation of the same.
  • Implement Quality Improvement Measures.
  • Reduce non-compliance in Packaging Departments with an objective of enhancing the quality with respect to all points (Documents, System, Procedure, Planning).

DESIRED SKILLS

  • Experience in the Packaging department of a reputed pharmaceutical organization.
  • Thorough knowledge of softwares and equipements required in packaging.
  • Experience in quality, documentation, planning and regulatory procedures and compliances required for packaging department.
  • Should have excellent planning and coordination skills.
  • Must have a keen eye for details.
  • Should be willing to work in a dynamic environment.
  • Should be a team player

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