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7.0 - 11.0 years
0 Lacs
ahmedabad, gujarat
On-site
You will be responsible for preparing and reviewing validation documents such as Area Qualification for new facilities, Factory Acceptance Test (FAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Control System Qualification, commissioning, validation & re-qualification, and Revision Qualification for equipment/utilities/facilities. You will generate reports that summarize results, specifications, and acceptance criteria. Your role will also involve authoring documents in ValGenesis. In addition, you will track SOPs due for review, circulate them for comments, update comments, initiate change control, initiate ERA workflow, and follow up fo...
Posted 3 months ago
4.0 - 8.0 years
0 Lacs
ahmedabad, gujarat
On-site
You will be responsible for handling production equipment including vial washing & Depyrogenation tunnel, Autoclave, Manufacturing, Steam air sterilizer, Laundry area, Vial coding (Domino), and external vial washing. Additionally, you will be in charge of the requalification/qualification of equipment such as autoclave, vial washing, and tunnel. Your duties will also include managing the auto CIP & SIP process of manufacturing tanks, as well as having knowledge about audit trails and data backup. Familiarity with computer systems like eBMR, PLC, and SCADA will be essential for this role. Furthermore, you should possess knowledge about change control, regulatory affairs, corrective and preven...
Posted 4 months ago
5.0 - 8.0 years
5 - 8 Lacs
Bengaluru, Ramanagara
Work from Office
Role & responsibilities Incharge for QMS activities, Preferred candidate profile Should have good knoledge about QMS, Validation, calibration , qualification, re-qualification, change control. CAPA, OOS, OOT & Investigation. Mainly for all Process equipments and Utility ( HVAC System, Purified System, Refrigerator System, Air Compressor System & Boiler ) Exposure with Regulatory Aduits.
Posted 5 months ago
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