Werum PAS X MBR Designer
Shine.com
- Location
- Mumbai, Maharashtra, India
- Job type
- Full-time
Required skills
- compliance
- cross-functional
- SAP
- serialization
- ERP
- batch Records
About the role
Shine.com
Website:
shine.com
Job details:
MBR Designer
- Strong expertise in Werum PAS-X MES MBR,GMBR,PMBR,etc. designing and Validation
- Knowledge of pharmaceutical manufacturing processes and regulatory compliance (GMP, GAMP 5, CFR Part 11).
- Experience with MES with ERP (SAP), L2/L3 automation systems, and serialization platform
- Understanding of data integrity principles and validation processes.
Responsibilties
- Design and configure Master Batch Records (MBRs) in Werum PAS-X according to client manufacturing processes.
- Collaborate with process engineers and QA teams to ensure compliance with GMP and data integrity.
- Validate and test MBRs to meet regulatory and operational requirements.
- Support MES implementation projects and troubleshoot issues related to MBR design.
- Work closely with cross-functional teams to harmonize processes and promote standardization across sites.
This job is provided by Shine.com
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