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 current 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 current or modified facilities and equipments.
Handling of Trackwise, Documentum (D2), ZYTIMS, SAP and LIMS function.

Role: Production &
Manufacturing - Other,

Industry Type: Pharmaceutical &
Life Sciences,

Department: Production, Manufacturing &
Engineering,

Employment Type: Full Time, Permanent

Role Category: Production &
Manufacturing - Other

Education

UG: Any Graduate

PG: Any Postgraduate

Key Skills

Skills highlighted with ‘‘ are preferred keyskills

GMP

ProductionCGMP

📌 Gmp Coordinator Production Bharuch
🏢 Zydus Lifesciences
📍 Bharuch