Asst Mgr - Production (Downstream)

TigerHire; Maharashtra; Presencial; INR 350.000 - 520.000; Jornada completa

Descripción de la vacante

TigerHire is seeking a detail-oriented manufacturing professional in Maharashtra to perform activities per BMR and SOPs, ensuring batch readiness and compliance with cGMP standards. You will manage batch records, schedules, and on-floor documentation while supporting SAP S/4 HANA operations and ECR processes.

Responsibilities include the execution of CIP/SIP, equipment readiness, and participation in self-inspections with a focus on regulatory adherence and safety on the shop floor.

Formación

• Familiarity with cGMP and QA systems.
• Attention to detail in batch documentation and deviation handling.
• Safety-conscious with regulatory compliance awareness.

Responsabilidades

• Perform manufacturing activities per BMR and SOPs.
• Maintain batch records and related documents for QA review.
• Prepare shift and batch schedules and ensure readiness for manufacturing runs.
• Operate SAP S/4 HANA for SOPs, BMR and ECR access.
• Participate in online BMR reviews on the shop floor.

Herramientas

SAP S/4 HANA

TrackWise

Descripción del empleo

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.