Biotechnology Expert QA Operations Bioconjugation | Biotechnologe (m/w/d)
Daiichi Sankyo Europe GmbH
Job Summary
This role is for a dedicated Biotechnology Expert in QA Operations, focusing on bioconjugation within a GMP-regulated environment. The expert will play a crucial part in establishing and maintaining QA-specific processes, collaborating closely with project teams and external service providers. Key responsibilities include developing and evolving contamination control strategies, supporting process validation and qualification activities, and reviewing essential documents like SOPs and risk analyses. After commissioning, the role involves ongoing QA oversight, managing change control processes, investigating deviations, and preparing for audits and inspections. This position is ideal for a professional committed to quality assurance in biotechnology, eager to contribute to a company focused on improving patient lives globally, particularly in cardiovascular and oncology fields.
Required Skills
Education
University degree (preferably Master's) in Biotechnological Manufacturing Processes or Biotechnological Analytics
Experience
- At least 2 years of Quality Management experience in a GMP-regulated environment
- Ideally, additional experience in bioconjugation within a GMP-regulated environment
- Inspection experience, including US-FDA, is desirable
Languages
Additional
- Willingness to actively contribute to building new areas for Daiichi Sankyo within a project team.
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