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Life Sciences CQV Professional
2 weeks ago
Pharmatec Srl is seeking an experienced Clean Utilities Specialist to join our team in Copenhagen, Denmark. This role offers opportunities to work on high-impact projects within the Life Sciences industry.
About the Job:This is an exciting opportunity for a mid-senior level professional to take on a leadership role in CQV activities for Clean and/or Black Utilities systems.
Key Responsibilities:- Lead and execute CQV activities for Clean and/or Black Utilities systems.
- Develop and review CQV documentation, including URS, FDS, FAT, SAT, IQ, OQ, and PQ.
- Collaborate with cross-functional teams to ensure compliance with GMP, FDA, and EU regulations.
- Identify and resolve technical issues, ensuring project timelines and deliverables are met.
- At least 5 years of experience in CQV within the Life Sciences industry.
- Proficiency in Clean and/or Black Utilities systems (e.g., purified water, WFI, HVAC, steam, compressed air, wastewater).
- Familiarity with ISPE guidelines, ASTM E2500, and regulatory requirements.
- Strong analytical and problem-solving skills, with the ability to work in a fast-paced environment.
- Availability to start in one month.