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Enzene
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Assistant Manager- Engineering (Instrumentation)

Assistant Manager- Engineering (Instrumentation)

9 - 12 years

|

10 - 13 Lacs

Posted:13 hours ago| Platform:

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Skills Required

instrumentation engineering automation instrumentation engineering instrumentation stratagies calibration

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Define and implement Instrumentation strategies including roadmaps, tools, and approaches across the organization.
Participate in design and architectural reviews of proposed Instrumentation solutions across R&D and Manufacturing project teams.
Should have good understanding of SOPs preparation, Change management, Deviation, QRM and other QMS related to engineering.
Should have personally faced major regulatory audits like USFDA, EMA, TGA, ANVISA, PMDA, etc
Should have good understanding of Plant Automation, Calibrations, process manufacturing, Quality Systems, and regulatory environment.
Prepare, Execute, document the annual calibration planner. Lead or support the vendor activities of external vendors for Calibration. Keep calibration reports & certificates updated.
Collaborate with key stakeholders and get clearance for instrument availability for calibration.
Develop business processes, guidelines, and training for the MES system.
Mange and involve into on going capital projects and modification related to Automation & Instrumentation in Engineering.
Should have good exposure and responsible manager for regulatory and customer audit. Should be able to face regulatory audits as Calibration SME.
Should be able to draft and finalize audit observation response related to calibration & Instrumentation.

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