Manager, Q&v And Digitalization Quality

Roche UK

Shanghai, China
Qualification and validation processes
Computerized system validation
Data integrity management
Responsible for Quality oversight of the planning and execution of all qualification and validation activities within PT China, including but not limited to equipment qualification, process validation, cleaning validation, method validation, digital systems validation and technical transfer, to ensure the compliance with company policies and requirements, global standards & procedures, and all relevant GxP regulations

Job Summary

  • Responsible for Quality oversight of the planning and execution of all qualification and validation activities within PT China, including but not limited to equipment qualification, process validation, cleaning validation, method validation, digital systems validation and technical transfer, to ensure the compliance with company policies and requirements, global standards & procedures, and all relevant GxP regulations.
  • Responsible for Quality oversight of the roll out of IT and digital systems in GxP areas is compliance with global Quality Requirements and relevant regulation requirements.
  • At Roche you can show up as yourself, embraced for the unique qualities you bring.

Matching Summary

Responsible for Quality oversight of the planning and execution of all qualification and validation activities within PT China, including but not limited to equipment qualification, process validation, cleaning validation, method validation, digital systems validation and technical transfer, to ensure the compliance with company policies and requirements, global standards & procedures, and all relevant GxP regulations.

Skills & Requirements

Must-have

  • Qualification and validation processes
  • Computerized system validation
  • Data Integrity management
  • GxP regulations knowledge
  • Pharmaceutical industry experience

Nice-to-have

  • Coaching colleagues
  • Cross-functional leadership
  • Navigating complex situations
  • Focus on value and customer

Key Requirements

  • 7 or more years’ work experience
  • 3 or more years’ GMP facility experience
  • Bachelor Degree in relevant discipline

Work Rights

Not specified

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