Pharmaceutical IT Systems Specialist

17 hours ago


Ghaziabad, Uttar Pradesh, India beBeeExpert Full time ₹ 20,00,000 - ₹ 30,00,000

Key Responsibilities

  • 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.
Requirements
  • Bachelor's degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.
  • Preferred: Master's degree with specialization in Industrial Automation, Pharmaceutical Technology, or a related technical field.
  • GAMP 5 for system validation in regulated environments.
  • CSV for compliance with GxP.
  • MES Platform Certifications.
  • 21 CFR Part 11 Compliance Training for electronic records and signatures.
  • 6 to 8 years of experience.

 

Desirable Skills
  • Knowledge of data analytics tools.
  • Edge Cloud deployment experience with IoT and IIoT.
  • L2 integration with MES.
  • MES integration with SAP.
  • Understanding of network and databases.


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