Quality Assurance Officer
lupin ltd
Work from Office
Full Time
Min. 1 yearJob Description
Officer - Quality Assurance
Job Description
- GMP, GLP, Data Integrity, Regulatory guidelines (USFDA, MHRA, WHO).
- Visiting to DS manufacturing and warehouse facility to ensure that activities are being carried out by following GMP requirements, Regulatory requirement and as per approved procedures.
- To participate in the manufacturing investigation and CAPA finalization activity.
- Preparation and review the Risk Assessment and Mitigation Plan.
- Ensure that process and cleaning validation activities are being carried out by following approved protocols.
- Review of master document like study protocol, BPR, MFR etc.
- Review of executed Batch Processing Records for Batch Release.
- Review of Batch Dispatch Record and verification of dispatch activities in warehouse.
- Overall coordination for the APQR data compilation and APQR preparation activity.
- Preparation and review of Quality System SOPs & documents.
- Review of SOPs as per GMP requirements for all departments
Work Experience
1–4 years in IPQA or AQA in a regulated pharmaceutical environment.
Education
Post Graduation in BiotechnologyCompetencies
1. Strategic Agility3. Customer Centricity6. Process Excellence4. Developing Talent5. Result OrientationExperience Level
Mid LevelJob role
Job requirements
About company
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