GMP Compliance Specialist

2 days ago


Kongens Lyngby, Lyngby-Tårbæk Kommune, Denmark COWI Full time

About the Role:

We are seeking a skilled GMP Specialist to join our team at COWI. The ideal candidate will have a strong understanding of GMP requirements and risk-based approaches for pharmaceutical production.

Main Responsibilities:

  • Develop and implement qualification and validation concepts for new builds, refurbishments, reconstructions, and development projects.
  • Educate and guide project members on GMP requirements and ensure consistent quality and compliance within the GMP framework.
  • Manage GMP requirements in pharmaceutical projects to strengthen our position as a preferred partner and broaden our market presence.
  • Take responsibility for CQV activities on clean rooms, temperature-regulated rooms, utilities, and other GMP-regulated areas.

Requirements:

  • Strong understanding of GMP requirements and risk-based approaches for pharmaceutical production.
  • Expertise in developing strategies for equipment and facility qualification/validation.
  • Knowledge of clean room and containment-controlled facility design, including biosafety and GMO requirements.
  • Relevant academic background in engineering, biology, chemistry, or pharmacy.
  • Minimum 3 years of experience in the bio- and pharmaceutical industry, both in Denmark and internationally.
  • Strong communication skills in English (written/verbal), with Danish proficiency preferred.
  • Experience in QA or pharmaceutical production, internal training, and contributing to GMP and facility design.

What We Offer:

COWI is committed to creating a respectful and fair work environment where all employees have a sense of belonging and equitable opportunities to thrive and grow. We value diversity and inclusion, and we are an equal opportunities employer.


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