IT Systems Manager

2 weeks ago

Kota, Rajasthan, India beBeeMesimplementation Full time ₹ 1,50,00,000 - ₹ 2,01,00,000

Key Job Responsibilities:

  • MES Implementation: As the key stakeholder, you will represent site-specific needs during MES design, configuration, and deployment.
  • Validation Leadership: Lead IQ, OQ, PQ, UAT, and traceability matrix execution to ensure seamless validation processes.
  • Documentation Ownership: Oversee GxP documentation (URS, FS, DS, test cases, validation plans/reports) for compliance and efficiency.
  • MES Product Expertise: Develop in-depth knowledge of MES functionality and architecture to drive informed decisions.
  • Front-End Support: Serve as the primary point of contact for MES application issues and user support to ensure optimal system utilization.
  • Training & Adoption: Deliver comprehensive training programs and ensure user readiness for MES usage to maximize adoption rates.
  • Data Management: Assist in data collection, migration, and master recipe creation to maintain accurate and up-to-date data sets.
  • Audit Readiness: Ensure all documentation and systems are compliant and audit-ready to mitigate risks.
Requirements

You should possess hands-on experience with MES platforms or similar systems in GxP-regulated environments. Familiarity with global regulations such as FDA 21 CFR Part 11 and EU GMP is essential. A degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field is required. Preferred qualifications include a Master's degree with specialization in Industrial Automation, Pharmaceutical Technology, or related technical fields.

GAMP 5 certification for system validation in regulated environments and CSV certification for compliance with GxP are highly desirable. Strong communication and interpersonal skills, proactive problem-solving, high attention to detail, and a strong compliance mindset are also necessary. Experience with Werum (Korber Pharma) for pharma industry is a plus.

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