Quality Assurance - Executive/ Asst Manager Emcure

7.0 - 12.0 years

3 - 7 Lacs

sanand, ahmedabad

Work from Office

Roles and Responsibilities Ensure compliance with regulatory requirements for equipment qualification, utility qualification, area qualification, transport validation, smoke testing, injectables, sterile, injection, vial washing, isolators, insulators, terminal sterilizer, RABS, Automatic leak testing machine chambers. Utility qualification (HVAC, WFI, PW etc), Facility and Area Qualification. Air flow visualization study (Smoke study) Develop and implement effective QA procedures to maintain high standards of production. Collaborate with cross-functional teams to resolve quality issues and improve processes. Maintain accurate records of all QA activities, Prepare and develop IQ,OQ,PQ & RQ p...

Posted 2 weeks ago

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Senior Executive, Validation Engineering, Technical Writing Amneal Pharmaceuticals

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 1 month ago

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