- Date Posted19/08/2022
- Location (State / UT)
- Expiration date--
- Experience12 Years, 15 Years
- Desired QualificationBachelor Degree
- Salary in (₹)Negotiable
- QMS Management
- Batch Release
- Audit Support
- Documentation function oversight
- Review of Self Inspection/Regulatory Inspection/Customer Inspection observations for impact, coordinate with CFTs for immediate investigation, compliance response preparation, and implementation.
- Conduct periodic gap assessments in Quality Procedures and practices, escalate the risk factors to the function head and ensure implementation of agreed actions.
- Review of Documentation practices, document issuance procedures, review procedures for completeness of information, file labeling and archival systems periodically, and ensure documents prepared are readily retrievable.
- Responsible to coordinate with CFTs in planning for the readiness of Inspection, arrangement of documents, identifying the SMEs for discussion during the inspection, and interacting with inspectors.
- Assessment of change controls for impact and review of mitigation plans for risk identified, ensure changes are implemented timely and closed.
- Assessment of Deviations for Impact, Investigation mechanism, and root cause analysis for logical and scientific aspects.
- Quality metrics preparation and trend analysis
- Monthly review meeting presentation and escalation of risks associated with quality events.
- Tracking of quality events for potential overdue and ensuring timely completion of the investigation.
- Ensure CAPA’s proposed are adequate to prevent re-occurrence or occurrence
- Impart training to QA and CFTs on GxP
Required Education Qualification: B.pharma
Required Experience: 12 – 15 years