Operation Investigation Management Specialist

PPD (Thermo Fisher) UK

Gmp standards compliance knowledge
Deviation investigation experience
Capa and root cause analysis skills
This role ensures compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations

Job Summary

  • This role ensures compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations.
  • You will implement continuous improvement initiatives, conduct investigations, and maintain quality management systems to enable global healthcare advancement.
  • The position requires working independently and collaboratively in cross-functional teams to solve some of the world's toughest scientific challenges.

Matching Summary

This role ensures compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations.

Skills & Requirements

Must-have

  • GMP standards compliance knowledge
  • Deviation investigation experience
  • CAPA and root cause analysis skills
  • TrackWise or Master Control software
  • Internal audit and inspection support

Nice-to-have

  • Conversational German language skills
  • Cleanroom environment experience
  • Cross-functional team collaboration
  • Project management organizational skills
  • Technical writing documentation abilities

Key Requirements

  • Bachelor's degree with 2 years experience or advanced degree
  • Fluent English and conversational German (B2)
  • Experience in pharmaceutical/biotech manufacturing or QA
  • Knowledge of ISO 9001/13485 standards

Work Rights

Not specified

Tailored Resume

Cover Letter