Validation Manager Oxera Precision Tech Pvt. Ltd.

5.0 - 9.0 years

0 Lacs

karnataka

On-site

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 change requests, subcontractor change requests, and design change requests. You will also be responsible for audits, releasing production batches, document control, product release, managing the qualification process, projects, analysis of standards, and creating new tools. In terms of managerial responsibilities, you will act as the technical point of contact for the department, organize the team's work, ensure availability of resources, report malfunctions, ensure compliance with company rules and the quality system, provide guidance, training, participate in recruitment, monitor integration/training, communicate information, escalate problems, conduct interviews, and motivate the team. The ideal candidate should have knowledge of quality control, experience in design qualification, installation qualification, operational qualification, performance qualification, writing skills, proficiency in IT tools, fluency in English, project management experience, familiarity with CDSCO regulations, and skills such as rigor, organization, analytical ability, communication, good writing skills, management, leadership, conviction, and team spirit.,

Posted 1 week ago

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