Dy Manager - Production (Upstream)

USV; Navi Mumbai; On-site; INR 300,000 - 600,000; Full time

Job summary

USV in Navi Mumbai seeks an experienced manufacturing professional to perform and supervise batch manufacturing activities in a cGMP environment. The role involves managing BMR/SOP-driven tasks, ensuring timely QA documentation, and coordinating changeovers with adherence to safety and regulatory norms.

The candidate will work with SAP S/4HANA for SOPs, BMR and ECR, support validation activities, and maintain equipment and inventory as part of daily operations on the shop floor.

Qualifications

• Experience with batch manufacturing and manufacturing records (BMR).
• Knowledge of SOPs and QA processes in a GMP setting.
• Familiarity with SAP S/4HANA and TrackWise or related quality systems.
• Understanding of validation concepts (URS/IQ/OQ/PQ) and change controls.

Responsibilities

• Perform manufacturing activities per BMR and SOPs.
• Manage batch-related documents in the manufacturing area.
• Prepare shift and batch schedules.
• Ensure readiness for batch manufacturing.
• Execute and monitor activities in compliance to cGMP.
• Oversee changeovers and document submission to QA.
• Decontaminate and dispose bio-waste.
• Prepare MCB/WCB as required.
• Operate CIP/SIP of equipment (manual or automated).
• Follow safety norms in the manufacturing area.
• Self-inspect area for regulatory compliance.
• Operate SAP S/4HANA for SOPs, BMR and ECR.
• Operate TrackWise Digital (TWD).
• Prepare URS for equipment (validation context).
• IQ/OQ/PQ activities for new equipment.
• Prepare/Review Quality documents (deviations, OOS, CAPA).
• Process orders, batch records, and material usage notes.
• Assist in preventive maintenance and inventory management.

Skills

cGMP knowledge

Documentation handling

SAP S/4HANA

Tools

TrackWise

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.