Senior Scientist, Quality Assurance
AGC Biologics
- København
- Permanent
- Fuldtid
- Overseeing the Quality Assurance review and approval of all technical documents, including but not limited to:
- Change Controls
- Deviations
- CAPAs
- Risk assessments
- SOPs
- Validation Plans
- Requirements Specifications
- Qualification Protocols and Reports
- Conducting GEMBA walks in GMP areas
- Communicating with internal and external stakeholders to resolve and clarify any points of issue
- Be part of setting standard for Qualification, Calibration, EM, cleaning and other Facility and engineering activities.
- A science-based degree
- Experience working in or directly supporting manufacturing operations in a drug substance/product manufacturing site
- Prior biopharmaceutical experience is desirable
- Thorough understanding of Good Manufacturing Practice (GMP) principles and guidelines
- Experience with the qualification of GMP facilities, equipment, and computerized systems
- Knowledge of Data Integrity principles
- Strong decision-making skills and a proactive attitude
- Excellent written and verbal communication skills
- Ability to work efficiently in a fast-paced, matrix environment
- Ability to meet deadlines and effectively manage multiple tasks
- Flexibility to adapt to changing business needs and priorities.