10 Sep
|
SHUKRA PHARMACEUTICALS
|
Uttar Pradesh
10 Sep
SHUKRA PHARMACEUTICALS
Uttar Pradesh
Position Designation: Test Lab Consultant Department: Quality / R&D; / Regulatory Engagement: Consultant / Part time / Project-based Location: Noida / Gurugram, India Reporting To: Head – Quality / Operations 1. Role Objective The Test Lab Consultant will be responsible for providing technical and strategic guidance for the planning, establishment, qualification, operation, and continuous improvement of testing laboratory facilities for medical devices. The consultant will support the organization in defining appropriate test methods, selecting test equipment, developing test protocols, evaluating external and internal laboratory capabilities, and ensuring that testing activities comply with applicable ISO, IEC, BIS, CDSCO and other relevant regulatory requirements . 2. Key Responsibilities A. Test Laboratory Setup & Planning Develop the overall test laboratory concept, infrastructure and equipment requirements. Prepare a comprehensive Test Laboratory Master Equipment List . Define equipment specifications, capacity and performance requirements. Recommend suitable test instruments,
fixtures, gauges and measurement systems. Support vendor identification, technical evaluation and comparison of quotations. Define laboratory layout, utilities, environmental requirements and safety provisions. Establish requirements for calibration, maintenance and equipment qualification. B. Medical Device Testing Provide technical guidance for testing of medical devices, including as applicable: Electrical safety testing EMC testing Mechanical and structural testing Environmental testing Performance and functional testing Software / firmware verification support Battery and electrical system testing Biocompatibility test coordination Packaging and transportation testing Shelf-life and accelerated-aging studies Sterilization-related testing Usability-related verification support Reliability and endurance testing Risk-control verification testing The consultant shall identify when testing
📌 Test Lab Consultant – Medical Devices (Uttar Pradesh)
🏢 SHUKRA PHARMACEUTICALS
📍 Uttar Pradesh