Senior Pharmaceutical Systems Manager

21 hours ago


Vijayawada, Andhra Pradesh, India beBeeIndustry Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
IT Manager Job Description

This role is responsible for overseeing the successful implementation of the Manufacturing Execution System (MES) and L2 at the site.

The ideal candidate will have 6-8 years of experience in the pharmaceutical industry, including technical and functional expertise in MES & L2 systems.

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:

  • Bachelors degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.
  • Preferred: Masters degree (e.g., MBA, M.Tech, M.Pharm) with specialization in Industrial Automation, Pharmaceutical Technology or related technical fields.
  • Specific Certification: GAMP 5 for system validation in regulated environments.
  • CSV (Computer System Validation) for compliance with GxP.
  • MES Platform Certifications e.g., Werum PAS-X, Siemens Opcenter, or Rockwell.
  • 21 CFR Part 11 Compliance Training for electronic records and signatures.

The IT Manager plays a vital role in supporting the successful implementation of the MES & L2 system. This includes representing site-specific needs during MES design, configuration, and deployment, as well as managing GxP documentation and leading validation activities. The ideal candidate will have a strong background in engineering, computer science, or a related field, and will be certified in GAMP 5 and CSV. Additionally, they should have experience with MES platform certifications and 21 CFR Part 11 compliance training. If you are a motivated and detail-oriented professional looking to make a meaningful impact in the pharmaceutical industry, this could be the perfect opportunity for you.



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