Master Batch Record Designer

hace 1 semana

Sant Cugat, Barcelona, España Oxford Global Resources A tiempo completo

Job Title: Master Batch Record Designer

Department:
Manufacturing / MES Design

Purpose of the Role

The Master Batch Record (MBR) Designer is responsible for consolidating process requirements and translating them into compliant, validated, and optimized electronic Master Batch Records within the Manufacturing Execution System (MES). This role ensures alignment with GMP standards, client's guidelines, and other applicable regulations.

Key Responsibilities

  • MBR Design & Configuration
  • Design and configure electronic Master Batch Records (MBRs) in the MES system, ensuring alignment with process requirements and compliance standards.
  • Program and parameterize each stage of the manufacturing process within MES (e.g., PAS-X MES Suite).
  • Lifecycle Management
  • Coordinate the lifecycle of MBRs, including creation, updates, and retirement, in accordance with GMP and client's standards.
  • Maintain and update Standard Operating Procedures (SOPs) related to MBR design and management.
  • Data Management
  • Manage master data related to MBRs and equipment within MES.
  • Create and maintain MBRs for new SKUs, process variations (PV), and line changes (PVL).
  • Validation & Compliance
  • Ensure MBRs are verified and validated according to regulatory and internal quality requirements.
  • Support internal and external audits related to MBR design and MES configuration.
  • Continuous Improvement
  • Participate in quality improvement initiatives to optimize MBR design and MES performance.
  • Identify opportunities and risks in MBR processes and propose actionable solutions.

Profile & Requirements

  • Education:
  • University degree in Engineering, Computer Science, or a related field.
  • Experience:
  • Minimum of 5 years of experience in MBR design using MES systems (preferably PAS-X MES Suite).
  • Knowledge & Skills:
  • Strong understanding of GMP and pharmaceutical manufacturing processes.
  • Proficient in MES systems and electronic batch record design.
  • Excellent communication and presentation skills.
  • Ability to collaborate across local and global teams.
  • Fluent in English.

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