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 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,

Posted 3 days ago

Apply

Senior Executive/Assistant Manager - Production Zydus Group

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 preventive actions (CAPA), and environment, health, and safety (EHS) activities. The ideal candidate will have a Bachelor's or Master's degree in Pharmacy, along with 4 to 8 years of experience in the field. Previous experience at Zydus for 12 to 24 months is preferred. This position is based in the Production Department at Zydus Pfizer in Ahmedabad.,

Posted 1 month ago

Apply

Senior Executive Desano

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 1 month ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.