Senior Manufacturing Execution Systems Specialist

6 hours ago

Allahabad, Uttar Pradesh, India beBeeManufacturing Full time ₹ 1,00,00,000 - ₹ 1,20,00,000
Job Summary

We are seeking an experienced professional to support the successful implementation of our Manufacturing Execution System (MES) at our Halol or Baska location. This role ensures that site-specific manufacturing processes are accurately captured and reflected in the global MES solution.

The ideal candidate will have a strong understanding of pharma shop floor operations and regulatory requirements, as well as prior hands-on experience with MES platforms or similar systems in GxP-regulated environments.

This includes a deep understanding of system functionality, configuration, and compliance requirements. The candidate should also be familiar with audit processes and documentation expectations.

Areas Of Responsibility:
  • 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.
Required Skills And Qualifications:

Bachelor's degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field is required.

Prior experience with Werum (Korber Pharma) for pharma industry is highly beneficial.

Certification in GAMP 5 for system validation in regulated environments and CSV (Computer System Validation) for compliance with GxP is necessary.

Familiarity with 21 CFR Part 11 Compliance Training for electronic records and signatures is also required.

Benefits:

We offer a competitive compensation package and opportunities for career growth and development.

Our company prioritizes employee safety, health, and wellbeing.

We foster a collaborative and inclusive work environment.

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