03 Nov
|
USV Private
|
India
Job Responsibilities
• Execution and Recording:
• 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)
• Validation/ Revalidation:
• Preparation of URS for the equipment.
• IQ, OQ and PQ of current equipment.
• Execution of validation / revalidation activities pertaining to Manufacturing processing area.
• Requisition for Issuance:
• Process order, batch manufacturing records.
• Material / stock solution used in process and routine use.
• 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
• To co-ordinate departmental training (DTC Role)
• 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.
• Responsible for training of the team.
📌 Dy Manager (India)
🏢 USV Private
📍 India