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GMP coordinator
2 weeks ago
Production GMP coordinator
- To initiate change control, preparation of draft documents (Existing and proposed) of change control. To discuss the changes with QA and to take approval.
- To initiate investigation and preparation of OOS, OOT and deviation investigation report of respective plant and ensure timely closer of documents.
- Preparation of new SOP and revised existing SOP as per requirement and initiation in documentum software and to take approval.
- To perform daily GMP round in respective plant and ensure compliance and online documentation.
- Monitor the Change control, CAPA and deviation in track wise system and its tracking and closures of respective plants and ensure timely closer of documents.
- To give training on approved documents, awareness session and ensure compliance of training of all employee of respective plant documents.
- Preparation of validation protocol and reports and verify that the validation protocols and reports are reviewed and approved.
- Analyse observations in order to compliance to cGMP systems & regulatory requirements.
- Involve in qualification of new or modified facilities and equipments.
- Handling of Trackwise, Documentum (D2), ZYTIMS, SAP and LIMS function.
