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Quality Manager WetLab
Choosing Capgemini means choosing a place where you’ll be empowered to shape your career, supported by a collaborative global community, and inspired to reimagine what’s possible. Join us in helping leading Consumer Products and Retail Services (CPRS) organizations unlock the value of technology and drive scalable, sustainable growth.
Your Role;
| The current scope of work demands highly specialized expertise across multiple regulatory and quality standards governing medical laboratories, device validation, and testing environments. These include: ISO/IEC 17025 – Testing & Calibration Laboratories ISO 15189 – Medical Laboratory Quality Management ISO 13485 – Medical Devices Quality Management Systems Regulatory frameworks (FDA, WHO, CLSI) NABL compliance and audit readiness Additionally, the work involves critical quality processes such as validation, CAPA, risk management, data integrity, and audit handling, which are essential to maintain compliance, accreditation, and client commitments. Skill Gap in Internal Resources A detailed internal capability assessment indicates that while the team possesses strong foundational knowledge in engineering and testing, there is no single internal resource (or combination) with sufficient depth and hands-on experience across the following required competencies: End-to-end implementation and maintenance of ISO/IEC 17025, ISO 15189, and ISO 13485 QMS frameworks Practical exposure to regulatory expectations (FDA, WHO, CLSI) in a medical laboratory setup Proven experience in: CAPA management and effectiveness checks Root Cause Analysis (5 Why, Fishbone) Risk management and deviation handling Change control systems Internal and external audit execution Strong expertise in: QMS documentation (SOPs, records, document control in audit-ready format) Data integrity principles (ALCOA+) Equipment qualification (IQ, OQ, PQ) Training and competency frameworks Laboratory-specific experience: Process and method validation Sample handling and traceability Calibration and uncertainty considerations Ability to establish and monitor: Quality metrics and KPIs Statistical trend analysis |
What You’ll Love About Working Here
We value flexibility and support our employees with hybrid work options and adaptable schedules to maintain a healthy work-life balance. Our inclusive culture brings together diverse professionals committed to growth, innovation, and excellence. You’ll have access to continuous learning opportunities and certifications in emerging technologies like cloud and AI.---
About Us
At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.Capgemini is a global business and technology transformation partner, helping organizations accelerate their dual transformation to address the evolving needs of customers and citizens. With a strong 55-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs—from strategy and design to operations.To achieve this, Capgemini draws on the capabilities of its 360,000 team members in more than 50 countries, all driven by the purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization with market-leading capabilities in digital, cloud, and data.
Pune, IN
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