Job Description
Please Note: - SHOULD HAVE WORKED IN REGULATED PLANTS. \PLANTS WITH EU , MHRA , US FDA APPROVALS.
- SHOULD HAVE WORKED FOR US FDA APPROVED COMPANY (MUST)
- Effective implementation and monitoring of Quality Management System.
- Responsible for Authorization of SOPs as per the procedure.
- Responsible for approval of master documents for example Batch manufacturing record, validation and qualification protocols, Site Master File, validation master plan, Product Specification including their revision.
- Responsible for approval of process validation, cleaning validation and qualification protocol and Report and executed validation activities.
- Responsible for release / dispatches of Finished Product as per the SOP.
- Responsible for department and cross functional department training.
- Responsible for review of Quality Manual.
- Approval of the vendor or supplier of the materials as per the SOP.
- Approval and monitoring of contract service providers of GMP related outsourced activities. •
- Responsible for storage, archival and retention of documents and records as per SOP.
- Monitoring of compliance with the requirements of current Good Manufacturing Practice.
- Ensuring that a timely and effective communication and escalation process exist to raise quality issues to the management.
- Participation in the Quality Management Reviews of process performance, Product Quality and of the quality management system.
- To ensure timely completion, review and approval of APQR as per the procedure and recommend CAPA if any.
- Responsible for approval of Deviation, Change Control, Market Complaints, OOS, OOT, Product
- Recall, Quality Risk Assessment, Manufacturing Incidents and laboratory incidents as per
- procedure.
- To conduct investigation and Root Cause Analysis to design the CAPA for the failures occurred in the plant.
- To Conduct self-inspection as a lead auditor as per the procedure. Monitor the effective execution of self-inspection and suggest the CAPA to the audit findings.
- Responsible for regulatory and customer audit compliance and verification of CAPA.
- To ensure timely review and revision of SOPs of all the departments and its issuance and retrieval as well maintenance of master SOPs, to ensure effective compliance of SOP management.
- Responsible for audit of manufacturer and supplier of Raw material and packing material as per the vendor approval SOP.
- Responsible for rejection of Raw material, Packing material and finished product as per the SOP.