System Integration Specialist

5 days ago

Solapur, Maharashtra, India beBeemes Full time ₹ 20,00,000 - ₹ 25,00,000

We are currently seeking an experienced professional to fill the role of IT System Manager. The ideal candidate will possess a strong background in managing enterprise-level systems and ensuring adherence to global regulations.

The position requires a seasoned individual with 6-8 years of experience in the pharmaceutical industry, including technical and functional expertise in MES & L2 systems.

  • MES Implementation: Representing site-specific needs during MES design, configuration, and deployment.
  • Validation Leadership: Leading IQ, OQ, PQ, UAT, and traceability matrix execution.
  • Documentation Ownership: Managing GxP documentation (URS, FS, DS, test cases, validation plans/reports).
  • MES Product Expertise: Maintaining deep knowledge of MES functionality and architecture.
  • Front-End Support: Acting as the first point of contact for MES application issues and user support.
  • Training & Adoption: Delivering training and ensuring user readiness for MES usage.
  • Data Management: Supporting data collection, migration, and master recipe creation.
  • Audit Readiness: Ensuring all documentation and systems are compliant and audit-ready.

Educational qualifications include a Bachelor's degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field. A Master's degree is preferred.

Certifications such as GAMP 5, CSV, and 21 CFR Part 11 Compliance Training are also required.

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