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Specialist Mbr Designer

2-5 years
Not Disclosed
10 Jan. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Specialist Master Batch Record (MBR) Designer

Locations:

  • Ljubljana
  • Barcelona Gran Vía
  • Hyderabad (Office)
  • Prague

Time Type: Full-time
Job Requisition ID: REQ-10028575

Role Overview:

The Specialist MBR Designer is responsible for supporting the design and implementation of Master Batch Records (MBRs) within Manufacturing Execution Systems (MES), particularly during project deployments and site operations. This role plays a key part in ensuring the smooth operation and continuous improvement of MES systems across Novartis sites, significantly contributing to the organization’s efficiency, compliance standards, and process harmonization.

Key Responsibilities:

1. MBR Design & Process Support

  • Design and update Master Batch Records (MBRs) to align with global core processes.
  • Provide MBR design and business process support during MES implementation projects and for operating sites.
  • Enforce process standardization and harmonization across Novartis sites.

2. MES Training & Best Practice Sharing

  • Responsible for delivering MES training sessions across Novartis sites.
  • Share best practices to ensure consistent processes across global locations.

3. MES Configuration & Master Data Support

  • Offer support for MES business configuration and master data across the sites.
  • Collaborate with both global and local teams in performing site fit-gap analysis to prepare for MES project deployments.

4. Documentation & Standardization

  • Assist in the update of standard operating procedures and global guidelines related to MES and MBR design.
  • Actively participate in MES communities of practices for continuous improvement.

Required Qualifications & Experience:

Education:

  • Bachelor’s degree in Pharmaceuticals, Chemistry, or a relevant technical field.

Experience:

  • Experience in MBR design with MES systems like PAS-X or Opstrakker.
  • Previous experience in the pharmaceutical industry with a solid understanding of manufacturing processes.
  • Demonstrated ability to collaborate effectively with teams across different Novartis sites.

Languages:

  • Fluent English (both written and spoken).
  • Additional languages such as German and Slovenian are a plus.

Skills:

  • Analytical Thinking: Ability to evaluate complex processes and make improvements.
  • Communication Skills: Strong ability to communicate clearly across teams and with senior stakeholders.
  • Requirements Analysis: Experience in gathering and analyzing requirements for MES systems and MBR designs.

Why Join Novartis?

  • Join a dynamic, high-performing team working with cutting-edge technology and innovative systems in the pharmaceutical industry.
  • Contribute to global process improvement and standardization across Novartis sites.
  • Be part of an organization that fosters a collaborative and inclusive environment.

Diversity & Inclusion Commitment:

Novartis is committed to creating an inclusive work environment and building diverse teams that are representative of the patients and communities we serve.

🔗 Apply now to be part of a global, forward-thinking team!