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1. Self-inspection observation categorization, compliance response evaluate for adequacy and trending for any repeat incidents and escalation to site quality head.
2. Conducting walk through in QC, Production, Engineering, Warehouse and immediate compliance establishment by co-ordination with user department.
3. Review of regulatory guidance update and pharmacopoeia update, action plan preparation and compliance establishment by coordinating with user department.
4. Preparation of compliance response to the regulatory audit findings and ensure activities completion within the commitment dates.
5. Review and approval of Deviation reports, Change controls and CAPA.
6. Review and approval of OOS and OOT results.
7. Implementation of Risk Assessment for manufacturing process, area, equipment and others and mitigate the risk.
8. Tracking of compliance action status and to update the status periodically.
9. To support for preparation of annual periodical trend reports w.r.t data required for audit and compliance.
10. Handling of non-compliances as per applicable QMS for any gaps/ non-conformance.
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