Senior Scientific Expert Quality Control Specialist
Vor 5 Tagen
We are seeking a highly skilled Senior Scientific Expert Quality Control Specialist to join our team at CSL Behring. In this position, you will play a critical role in supporting the Quality Control activities and projects within our organization.
Key Responsibilities- Product Specifications: Develop and maintain product specifications, ensuring consistency and professionalism in the establishment and amendment of in-process, bulk, and filling specifications.
- QC Assessments: Conduct thorough assessments of CSL change requests as a QC assessor/coordinator, ensuring timely and professional completion.
- SOP Generation: Generate and edit owned SOPs in a professional and timely manner, ensuring compliance with regulatory requirements.
- Project Coordination: Coordinate QC projects as per scope, ensuring timely and professional completion.
- Administrative Support: Provide administrative support to the QC Operations Manager and departments as per client assignments.
- Regulatory Support: Support requests by authorities regarding reagents, control, and reference materials.
- Global Projects: Participate in global projects and cross-site activities, providing technical expertise and support.
- Technical Support: Provide technical support and collaboration in the resolution of technical questions or problems regarding batch release.
- QC OOX Results: Capture and edit summarizing QC OOX results in a consistent and professional manner.
- Global Partners: Establish and maintain contacts with global partners, ensuring effective collaboration and communication.
- Education: Bachelor or Technical High School in natural sciences, pharmacy, chemical engineering, or related field. Alternatively, laboratory technician with well-founded experience in the field of responsibility.
- Project Management: Project management qualification is an advantage.
- Industry Experience: Minimum of 5 years' experience in the pharmaceutical, biotechnology, or related industry with significant exposure to GMP or closely related environments.
- Analytics Experience: Microbiological, biological, chemical, or biochemical analytics in medicinal or pharmaceutical GMP environments.
- Language Skills: Fluent German and English language.
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular, and metabolic, respiratory, and transplant therapeutic areas.
Our Commitment to Diversity and InclusionAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. We strive to create an environment where everyone feels valued, respected, and supported.
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