Asst Mgr - Production (Downstream)

USV; Navi Mumbai; On-site; INR 350,000 - 700,000; Full time

Job summary

USV is seeking personnel to support manufacturing operations in the Navi Mumbai facility. The role involves conducting manufacturing activities per BMR and SOPs, maintaining batch records, and ensuring readiness for batch manufacturing with strict cGMP adherence.

The candidate will also handle documentation, equipment validation, CIP/SIP, safety, and self-inspections while coordinating with QA and support teams to ensure smooth production flows.

Responsibilities

• Perform the manufacturing activities as per the BMR and SOP’s.
• Batch related documents in manufacturing area.
• Preparation of shift schedule and batch schedule.
• Readiness related to batch manufacturing.
• Execution and monitoring of activities in compliance to cGMP.
• Execution of activities during product change over
• Checking and timely submission of Batch Manufacturing records to QA.
• Decontamination and disposal of bio waste.
• Preparation of MCB/WCB.
• Automated or manual CIP and SIP of equipment in the manufacturing area.
• Follow safety norms in the manufacturing area.
• Self-Inspection of manufacturing area and compliance as per regulatory norms.
• Operation of SAP S/4 HANA system for SOPs, BMR and ECR.
• Operation of track wise digital (TWD)
• Preparation of URS for the equipment.
• IQ, OQ and PQ of new equipment.
• Execution of validation / revalidation activities pertaining to Manufacturing processing area.
• Process order, batch manufacturing records.
• Material / stock solution used in process and routine use.
• Quality management system (filling/review of deviations, OOS, change control, CAPA and other quality system).
• PO, MFR, BMR, SOPs and other documents in the department.
• Protocol / Report Preparation
• Preventive maintenance of equipment in manufacturing area.
• Proper working of equipment and other ancillary items in manufacturing area.
• Compliance of area and equipment’s as per cGMP norms.
• Online BMR review at shop floor.
• Consumables/spares inventory management.

Job description

• Perform the manufacturing activities as per the BMR and SOP’s.
• Batch related documents in manufacturing area.
• Preparation of shift schedule and batch schedule.
• Readiness related to batch manufacturing.
• Execution and monitoring of activities in compliance to cGMP.
• Execution of activities during product change over
• Checking and timely submission of Batch Manufacturing records to QA.
• Decontamination and disposable of bio waste.
• Preparation of MCB/WCB.
• Automated or manual CIP and SIP of equipment in the manufacturing area.
• Follow safety norms in the manufacturing area.
• Self-Inspection of manufacturing area and compliance as per regulatory norms.
• Operation of SAP S/4 HANA system for SOPs, BMR and ECR.
• Operation of track wise digital (TWD)

B. Validation/ Revalidation:

• Preparation of URS for the equipment.
• IQ, OQ and PQ of new equipment.
• Execution of validation / revalidation activities pertaining to Manufacturing processing area.

C. Requisition for Issuance:

• Process order, batch manufacturing records.
• Material / stock solution used in process and routine use.

D. Preparation/Review of Documents:

• Quality management system (filling/review of deviations, OOS, change control, CAPA and other quality system).
• PO, MFR, BMR, SOPs and other documents in the department.
• Protocol / Report Preparation

5. Assist:

• Preventive maintenance of equipment in manufacturing area.
• Proper working of equipment and other ancillary items in manufacturing area.
• Compliance of area and equipment’s as per cGMP norms.
• Online BMR review at shop floor.
• Consumables/spares inventory management.