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Regulatory Compliance Expert

7 days ago

Copenhagen, Copenhagen, Denmark AM Group Full time

We are looking for a talented Regulatory Compliance Expert - Life Science to support our client in the Pharmaceutical Industry.

Job description:
  • Develop and implement environmental monitoring strategies to ensure compliance with GMP regulations.
  • Conduct risk assessments to maintain contamination control in classified areas.
  • Create and execute environmental monitoring plans, covering viable and non-viable particle testing.
  • Coordinate and perform environmental monitoring qualification activities (URS, DQ, IQ, OQ, PQ).
  • Provide operational expertise for environmental monitoring systems during commissioning and qualification phases.
  • Collaborate with automation engineers to provide technical insights on monitoring systems and data integrity.

About the role:

  • You will work in a dynamic team supporting a major project in Denmark.
  • You will contribute to ensuring the highest quality standards in environmental monitoring.
  • You will work closely with colleagues from various disciplines to achieve project goals.
Requirements:
  • You hold a Master's degree in Engineering or a related field.
  • You have at least 10 years of experience in environmental monitoring within the pharmaceutical industry.
  • You have a strong understanding of GMP guidelines, regulatory requirements, and data integrity principles.
  • You have experience in aseptic filling environments and cleanroom qualification.
  • You are proficient in environmental monitoring equipment and automation systems.
  • You are fluent in English.