Regulatory Compliance Expert
6 days ago
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.
- 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.
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