6 Performance Qualification Jobs

PROCESS VALIDATION ENGINEER Job Location: Pune Exp : 4 To 15 Years Salary : As per experience ABOUT IZIEL HEALTHCARE: IZiel Healthcare is an Engineering & Regulatory service provider working with global medical device manufacturers. We partner with customers to support them with all aspects of the Product Life Cycle. Employees are the key to success in our organization. We value our engineers and their skills in furthering the cause of helping lives. Thorough leadership, robust work planning methodology, and exceptional customer service are the key enablers of our success. POSITION DESCRIPTION: The Senior PV Engineer Process Validation will be responsible for planning, executing, and documen...

As a Senior Engineer in Gas Distribution Systems (GDS) and Fluid Systems, your role involves leading proposal and detailed engineering activities while enhancing the capability of the engineering team. You will play a crucial part in delivering top-notch technical solutions, engaging in technical discussions for business development, and establishing engineering standards within the organization. **Key Responsibilities:** - Lead the design and engineering of modular gas and liquid systems, encompassing gas generation units like N, O, H, blending, metering, blanketing, and pressure control skids. - Support the Business Development team by addressing technical queries (TQs) and offering optimi...

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...

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas. Following a new opportunity, we are currently looking for a Junior Consultant: Qualification & Validation (CQV) to join our team in an onsite project at Rupnagar (Chandigarh) Location. The ideal candidate should have 2+ years of experience in a similar role and be able to review and update P&ID, prepare Qualification Documents like Validation Plan, Design Qualification, User requirement specification, Installation Quali...

You will be working as a Validation Manager at EVOL ORTHO TECH located in Bengaluru, India. The company is involved in the manufacturing of knee orthopaedic implants for the Indian Market. Established as a greenfield project in 2025, EVOL ORTHO TECH is a Joint-Venture between a French and Mauritius Based Company. As a Validation Manager, you will report to the Quality & Regulatory Affairs General Manager and oversee a team of 3 members after ramp-up. The ideal candidate will hold a BE (MECHANICAL) degree or equivalent qualification. Your primary responsibilities will include managing process monitoring, material analysis tests, preparing qualification and validation files, handling process c...

Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (I...