MBR Designer Expert (PAS|X)
Club Vivanet · Mumbai · onsite · Posted 52d ago
Not disclosed5–7 yrsfulltimeSourced from
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About this role
We are transitioning from paper-based batch records to electronic batch records (eBR) using Werum PAS|X. The expert will lead MBR design, SAP integration, and validation/testing until Dec 2027, onsite in Navi Mumbai.
Must-Have Skills- PAS|X expertise: 5+ years hands-on, including 3+ years in MBR/GMBR design
- eBMR configuration: Ability to design/configure electronic batch records and PAS|X master data (equipment, materials, parameters)
- SAP integration: Practical experience connecting PAS|X with SAP ERP
- Pharma GMP: Strong knowledge of GxP compliance and CSV (IQ/OQ/PQ, UAT, integration testing)
- Onsite availability: Full-time, long-term presence in Navi Mumbai
- PAS|X certification: Versions 3.2/3.3/3.4 and PAS|X MBR Designer certification
- SAP background: Strong ERP knowledge and experience in global pharma projects
This role is ideal for a senior MES/MBR consultant who can:
- Lead MBR design workshops with process SMEs
- Configure PAS|X master data aligned to GMP standards
- Drive SAP-PAS|X integration testing and validation cycles
- Ensure audit readiness and compliance with FDA/EU regulations
- Commit to onsite engagement through Dec 2027
Sourced from foundit
Skills
CSV IQ OQ PQ UAT integration testingeBMR configurationPAS|X expertisePharma GMPGxP complianceIntegration