Csv Senior Compliance Advisor

ConvaTec Group

Deeside, United Kingdom
Hybrid
Gxp regulations and best practice
Computer system validation lifecycle management
Risk-based validation approach
The Computer Systems Validation (CSV) Senior Compliance Advisor will play an integral role in ensuring that IT managed GxP computerized systems and infrastructure are validated or qualified in accordance with corporate quality standards

Job Summary

  • The Computer Systems Validation (CSV) Senior Compliance Advisor will play an integral role in ensuring that IT managed GxP computerized systems and infrastructure are validated or qualified in accordance with corporate quality standards.
  • Key responsibilities include overseeing GxP impacting projects, ensuring compliance with regulatory requirements, and confirming systems are fit for purpose by meeting user requirements.
  • The role involves managing validation deliverables, coaching implementation teams, solving problems during the validation process, and maintaining up-to-date knowledge of evolving regulatory requirements.

Matching Summary

The Computer Systems Validation (CSV) Senior Compliance Advisor will play an integral role in ensuring that IT managed GxP computerized systems and infrastructure are validated or qualified in accordance with corporate quality standards.

Skills & Requirements

Must-have

  • GxP Regulations and best practice
  • Computer system validation lifecycle management
  • Risk-based validation approach
  • Validation deliverables development
  • Supplier assessment for IT services

Nice-to-have

  • Ability to influence and negotiate
  • Conscientious and highly committed
  • Rapid adaptation to new environments
  • Effective multitasking and prioritizing

Key Requirements

  • Bachelor’s degree in computer science, engineering life science or related field
  • 5 years experience with CSV validation lifecycle management
  • Minimum 2 years experience in pharmaceutical or Medical Device industry
  • Excellent understanding of industry regulations, standards, and guidelines

Work Rights

Not specified

Tailored Resume

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