Environmental Monitoring Strategist
4 days ago
About the Role
As a senior Environmental Monitoring Strategist, you will play a key part in ensuring our client's pharmaceutical facilities meet the highest standards of quality and regulatory compliance.
Your primary responsibility will be to develop and implement environmental monitoring strategies that align with Good Manufacturing Practice (GMP) regulations.
- You will conduct thorough risk assessments to identify potential contamination risks in classified areas.
- Developing and executing comprehensive environmental monitoring plans, including viable and non-viable particle testing.
- Coordinate and perform qualification activities for environmental monitoring systems, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Collaborate with automation engineers to provide technical expertise on monitoring systems and data integrity.
About You
- You hold an Engineering degree or equivalent university qualification at Master's level.
- A minimum of 10-15 years of experience in environmental monitoring within the pharmaceutical industry.
- Strong understanding of GMP guidelines, regulatory requirements, and data integrity principles.
- Experience in aseptic filling environments and cleanroom qualification is essential.
- Familiarity with environmental monitoring equipment and automation systems.
- Fluent in English.
- Willingness to join our Danish subsidiary under a local contract.
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