Pharmaceutical Manufacturing Sites Expert

13 hours ago

Gandhinagar, Gujarat, India beBeeManufacturing Full time ₹ 1,80,00,000 - ₹ 2,20,00,000
Key Functional Expert for Pharmaceutical Manufacturing Sites">

We are seeking a seasoned professional with 6-8 years of experience in the pharmaceutical industry, including technical and functional expertise in manufacturing execution systems (MES) & level 2 (L2) systems. The ideal candidate will ensure adherence to global regulations (FDA 21 CFR Part 11, EU GMP, GAMP5).

The Site SME MES Project is a key role responsible for supporting the successful implementation of MES & L2 at the pharmaceutical manufacturing sites. This position ensures that site-specific manufacturing processes are accurately captured and reflected in the global MES solution.

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 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.

Qualifications:

Bachelors degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.

Preferred qualifications: 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.

Required Skills and Qualifications:

  • Strong background in MES and L2 systems.
  • Expertise in system validation and quality assurance.
  • Proficiency in computer systems validation and compliance.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a team environment.

What We Offer:

This is a unique opportunity to join our team as a key functional expert for pharmaceutical manufacturing sites. You will have the chance to develop your skills and expertise while contributing to the success of our organization.

How to Apply:

If you are a motivated and experienced professional looking for a new challenge, please submit your application.

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