Dy Manager - Production (Upstream)

TigerHire; Maharashtra; Sur place; INR 260 000 - 420 000; Plein temps

Résumé du poste

TigerHire in Maharashtra is seeking a manufacturing operations professional to execute batch manufacturing in accordance with BMRs and SOPs. The role involves preparing shift and batch schedules, ensuring readiness for production changes, and maintaining strict cGMP compliance on the shop floor.

You will manage documentation, equipment validation activities, and the timely review of BMRs by QA. Experience with SAP S/4HANA in SOP/BMR workflows and knowledge of quality systems is preferred.

Responsabilités

• Manufacturing activities per BMR and SOPs.
• Batch related documentation in manufacturing area.
• Preparation of shift and batch schedules.
• Readiness for batch manufacturing.
• Execution and monitoring in compliance with cGMP.
• Submission of Batch Manufacturing Records to QA after product changeover.
• Decontamination and disposal of bio-waste.
• Preparation/Review of documents: Quality management system deviations, OOS, change control, CAPA, etc.

Description du poste

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.

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.