GMP Compliance Specialist
4 weeks ago
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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