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

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CQV Engineer- EVal PM Group

5.0 - 9.0 years

3 - 8 Lacs

Bengaluru

Work from Office

CQV Engineer Job Description To support the CQV service, we are now looking to recruit an Electronic Validation Administrator. The successful candidate will play a key role in supporting our Electronic Validation (Eval) capability while collaborating with our existing CQV delivery teams and customers to enhance and develop our overall CQV service delivery. The role requires the ability to manage the setup & administration of current EVal platform (Kneat) as well as future EVal software. The role will also require the administration of client EVal instances when required for projects. The successful candidate will work closely with client digital teams to agree the implementation of EVal on their projects, as well as communicating and integrating the CQV requirements between engineering and construction functions. This part time (hybrid) role will report to CQV Electronic Validation Lead based in the India offices. Responsibilities .Understand EVal strategy aligned with the company's overall objectives and vision. Ensure the digital platforms are in place and setup correctly to deliver the EVal service for our clients. Ability to interface with clients and build relationships to grow the EVal delivery business. Administration support on both internal and client Kneat platforms Ability to draft, review and approve electronic documentation Upkeep of PM Group CQV EVal template libraries Progress updates to manager at weekly work plans Qualifications .Ideally, a Primary Degree in an Engineering related discipline with 5+ years experience in CQV/pharma. Demonstrated capability & expertise in the use of EVal platforms- Preferably Kneat and/or Valgenesis. Ability to work on ones own initiative. Excellent communication skills. Past training with Kneat Academy advantage Why PM Group ? As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future

Posted 1 month ago

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