Quality Assurance Professional
9 hours ago
At Fujifilm Diosynth Biotechnologies, we are committed to developing and manufacturing innovative biological products. As a leading Contract Development and Manufacturing Organization (CDMO), our goal is to provide high-quality services that meet the needs of our clients.
About the RoleWe are seeking a dedicated Quality Assurance specialist to join our audit team. In this role, you will play a crucial part in ensuring compliance with relevant regulations, including API, drug, and medical devices standards.
Key Responsibilities:- Coordinate change controls, quality agreement revisions, and vendor assessments to ensure regulatory compliance.
- Negotiate supplier agreements with internal stakeholders to maintain high-quality partnerships.
- Manage the approved supplier list to guarantee adherence to Good Manufacturing Practices (GMP).
- Support TrackWise workflows and maintain accurate GxP records to ensure seamless operations.
- Review and approve minor audit observations and responses to prevent delays.
- Monitor Key Performance Indicators (KPIs) and Quality Management Reviews (QMRs) to identify areas for improvement.
- Bachelor's or Master's degree in a life science field.
- Minimum 3-5 years of experience in GxP QA and supplier management.
- Fluency in English; Danish fluency preferred.
- Excellent interpersonal skills and a positive attitude.
As a global leader in biotech manufacturing, we offer a dynamic work environment, opportunities for growth and development, and a competitive compensation package.
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