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As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Job Summary:
We are seeking a seasoned professional with 6-8 years of experience in the pharmaceutical industry, including technical and functional experience in MES & L2 systems.
The Site SME – MES Project is a key functional and technical expert responsible for supporting the successful implementation of the Manufacturing Execution System (MES) & L2 at the Halol & Baska pharmaceutical manufacturing sites. This role ensures that site-specific manufacturing processes are accurately captured and reflected in the global MES solution.
The SME is also accountable for leading site-level validation activities and technical owner responsibility, and managing all GxP documentation related to the MES & L2 system. The Site SME is the go-to authority for end-to-end MES product knowledge. This includes a deep understanding of system functionality, configuration, and compliance requirements.
The SME also serves as the first point of contact for any MES front-end application issues, supporting users in troubleshooting, training, and ongoing system usage post-go-live. The ideal candidate will ensure adherence to global regulations (FDA 21 CFR Part 11, EU GMP, GAMP5)
Previous experience with Werum (Korber Pharma) for pharma industry is a big plus
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.
