Specialist, Mbr Author

Merck Sharp & Dohme Corp

Telangana, India
Hybrid
Werum korber pas-x mes experience
Electronic master batch record design
Cgmp regulatory compliance knowledge
Merck Sharp & Dohme Corp is seeking a Specialist MBR Author to oversee the design, development, and deployment of electronic Master Batch Records (MBRs) using Werum/Korber PAS-X systems. The role requires expertise in manufacturing processes, compliance with regulatory standards, and strong analytical skills, offering a hybrid work environment

Job Summary

  • The Specialist acts as a subject matter expert to ensure the successful and compliant deployment of Werum/Korber PAS-X electronic Master Batch Records.
  • Responsibilities include identifying continuous process improvement opportunities and executing change control actions to maintain MES system state of control.
  • The role requires collaboration with project teams and the site Quality unit to foster quality decisions based on regulatory standards.

Matching Summary

Match Score: 85

Merck Sharp & Dohme Corp is seeking a Specialist MBR Author to oversee the design, development, and deployment of electronic Master Batch Records (MBRs) using Werum/Korber PAS-X systems. The role requires expertise in manufacturing processes, compliance with regulatory standards, and strong analytical skills, offering a hybrid work environment.

Skills & Requirements

Must-have

  • Werum Korber PAS-X MES experience
  • Electronic Master Batch Record design
  • cGMP regulatory compliance knowledge
  • Manufacturing process understanding
  • Change control execution

Nice-to-have

  • Biologics manufacturing principles
  • SAP system knowledge
  • L2 Systems Historian SCADA DCS
  • Strong analytical problem solving skills
  • High personal integrity and credibility

Key Requirements

  • Bachelor's Degree required
  • 4+ years MES support experience or 6+ years relevant MES experience
  • Minimum 3 years in production regulated industry
  • Direct experience with MBR and GMBR design

Work Rights

Not specified

Tailored Resume

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