Engineering Quality Associate Manager, Biologics

Roche UK

Shanghai, China
Csv and data integrity execution
Commissioning and qualification strategy
Gmp standards and guidelines
Ensure all aspects of CSV, Data Integrity and validation activities for the project are executed on time and in accordance with the C&Q / Validation Master Plan, local and global requirements, and applicable regulations

Job Summary

  • Ensure all aspects of CSV, Data Integrity and validation activities for the project are executed on time and in accordance with the C&Q / Validation Master Plan, local and global requirements, and applicable regulations.
  • As an integral part of the project quality team, this position report to Quality Head of Biologics, has overall responsibility for participating in project work streams, ensuring proper execution of design/qualification/validation strategies as well as providing support and guidance for quality processes and procedures during the project phase.
  • Create an environment with strong team spirit, timely and effective communication, sense of urgency and high motivation, and inspire teams to achieve short-term and long-term goals.

Matching Summary

Ensure all aspects of CSV, Data Integrity and validation activities for the project are executed on time and in accordance with the C&Q / Validation Master Plan, local and global requirements, and applicable regulations.

Skills & Requirements

Must-have

  • CSV and Data Integrity execution
  • Commissioning and Qualification strategy
  • GMP standards and guidelines
  • Risk-based approaches to C&Q
  • Aseptic Filling experience required
  • New DP facility project experience

Nice-to-have

  • Demonstrate VACC leadership behaviors
  • Embrace personal expression and open dialogue
  • Promote a positive safety culture
  • Embody PT Lean principles

Key Requirements

  • 10+ years work experience in Bio-pharma
  • 5+ years people or project management
  • Science Bachelor degree or above
  • Fluent English communication skills

Work Rights

Not specified

Tailored Resume

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