
AM/ Dy Manager- Packaging
6 days ago
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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