About The Role

Lead and Manage Instrumentation section at Enzene Biosciences. 2. Define and implement Instrumentation strategies including roadmaps, tools, and approaches across the organization. 3. Participate in design and architectural reviews of proposed Instrumentation solutions across R&D and Manufacturing project teams. 4. Should have good understanding of SOPs preparation, change management, Deviation, QRM and other QMS related to engineering. 5. Should have personally faced major regulatory audits like USFDA, EMA, TGA, ANVISA, PMDA, etc. 6. Should have good understanding of Plant Automation, Calibrations, process manufacturing, Quality Systems, and regulatory environment. 7. Prepare, Execute, document the annual calibration planner. Lead or support the vendor activities of external vendors for Calibration. Keep calibration reports & certificates updated. 8. Collaborate with key stakeholders and get clearance for instrument availability for calibration. 9. Willing to work in extended hours as and when required. 10. Develop business processes, guidelines, and training for the MES system. 11. Mange and involve into on going capital projects and modification related to Automation & Instrumentation in Engineering. 12. Should have good exposure and responsible manager for regulatory and customer audit. Should be able to face regulatory audits as Calibration SME. 13. Should be able to draft and finalize audit observation response related to calibration & Instrumentation. 14. Supporting to Unit-2 & R&D for anything related to Project execution and Breakdowns on need base.

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Assistant Manager

About The Role