Company Details

A leading Indian biopharmaceutical company based in Bangalore.The Company manufactures generic active pharmaceutical ingredients (APIs) that are sold in over 120 countries across the globe, including the developed markets of the United States and Europe. It also manufactures novel biologics, as well as, biosimilar insulins and antibodies, which are sold in India as branded formulations. Their biosimilar products are also sold in both bulk and formulation forms in several emerging markets.

Assignment Details

Our client, a Leading Indian Biopharmaceutical Company, is seeking to engage with a IT Product Manager to define the roadmap and lead the Implementation of Manufacturing Execution System (MES) for Biologics Manufacturing facilities globally (India and Malaysia).

Key Responsibilities:
- Collaborate with Business operations, Engineering, Quality units and other
stakeholders to understand the existing IT systems and derive road map
- Further collaborate with Vendors to finalize the scope of implementation
- Be the IT representative in MES implementation core team as IT System Owner/Product Manager for MES
- Lead the MES Interface & integrations with 3rd party applications (ERP, LIMS, VLMS, Equipment Calibration, Maintenance Systems, PLM, SCADA systems and IIOT)
- Review and approve MES Validation deliverables
- Engaging with manufacturing users, product admins, and site leads and conduct MES Product training workshops and facilitation across a range of stakeholders.
- MES application change management and Continual improvement

Skills Required

- Minimum 10 years of Industry experience (at least 5 years in Pharma or Biopharma industry)
- Implemented and change managed MES application at least in two manufacturing units. As part of core implementation team.
- Knowledge of informational and operational technologies (IT/OT), MES integration to enterprise systems.
- Very good knowledge of SDLC and Software Validation
- Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11, cGMP Annex 11, Data Integrity principles.
- Hands-on Configuration experience in handling designing solution in Manufacturing application like MES, Operations support systems and integrations.
- Experience in handling Werum/ PAS-X or Rockwell MES along with integration with SAP is an added advantage.
- Prior experience in working closely with IT/OT providers/vendors