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Amneal Pharmaceuticals logo

Senior Executive, Validation Engineering, Technical Writing

7 - 11 years

0 Lacs

ahmedabad gujarat

Posted:3 days ago| Platform: Shine logo

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Skills Required

validation commissioning authoring sops change control calibration preventive maintenance purchase order caliber area qualification factory acceptance test installation qualification operational qualification performance qualification control system qualification requalification revision qualification valgenesis era workflow data sheet quotes engineering activities qams

Work Mode

On-site

Job Type

Full Time

Job Description

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 for execution, approval, and closure. You will prepare Monthly Calibration Schedule and Preventive Maintenance Schedule as per US FO requirements. Reviewing Calibration reports and updating them on a daily basis will also be part of your responsibilities. Furthermore, you will be required to prepare, track Purchase orders, update data sheets, arrange quotes for new equipment as needed, and update the required status and database for engineering activities in an Excel sheet. Initiating QAMS documents in Caliber will also be one of your tasks. Qualifications: - B.E./B. Tech Experience: - 7 to 8 Years,

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