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.