MES MBR Verification lead
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Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
MES MBR Verification lead
Exp:-8yrs
Location: Hyderabad and Pune
Role Summary
Digital Factory Program (DFP) is a global initiative to standardize and digitalize manufacturing operations through integrated systems and optimized processes. A key component is the implementation of MES (PAS-X) with electronic batch records (eBR) to replace paper-based processes and enable review by exception.
As the MES MBR Verification Lead you will be responsible for ensuring the accuracy compliance and readiness of Master Batch Records (MBRs) designed for MES deployment. You will lead global verification activities coordinate with design teams and ensure adherence to regulatory and system standards.
- Review and verify global and localized MBRs for completeness accuracy and compliance with GMP and GxP requirements.
- Ensure alignment of MBRs with MES design principles and global templates.
- Validate integration points with ERP WMS LIMS and OT systems.
- Maintain global standards for MBR verification and documentation.
- Define verification protocols and checklists for MES deployments.
- Ensure adherence to Koerber PAS-X best practices and internal SOPs.
- Coordinate verification activities across global sites and deployment phases.
- Collaborate with MBR designers MES SMEs and site teams to resolve gaps.
- Support testing and dry runs to confirm MBR functionality before go-live.
- Act as the primary point of contact for MBR verification topics.
- Provide guidance and training to site teams on verification processes.
- Support audits and inspections related to MES and eBR compliance.
- Global MBR verification protocol and checklist.
- Verified and approved MBRs for MES deployment.
- Compliance reports and audit readiness documentation.
- Issue logs and resolution tracking for MBR gaps.
- Verification dashboards and KPIs.
- Bachelors or Masters degree in Engineering Life Sciences or related field.
- Experience in MES implementation and batch record design.
- Strong knowledge of GMP GxP and electronic batch record compliance.
- Experience with Koerber PAS-X MES and MBR lifecycle management.
- Fluent in English.
- Familiarity with ERP (Infor M3) WMS LIMS and OT system integration.
- Knowledge of validation and CSV principles.
- Strong documentation and audit management skills.
- Ability to manage global stakeholders and cross-functional teams
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