GMP coordinator - Production

This position is for Zydus Lifesciences, Ankleshwar unit - 2 in GMP coordinator role.

• 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.