Senior Scientific Expert QA Batch Release Support

For the area of Batch Release Support within our department Quality Management we are looking for a

Senior Scientific Expert QA Batch Release Support (BRS) 80%

The Batch Release department deals with the GMP-compliant release of intermediate and final products and thus ensures the high quality of our products towards our customers. As a Senior Scientific Expert QA BRS you are responsible for the electronic systems that support the release processes.

Skills and Responsibilities

• Responsible for the maintenance and continuous improvement of the QA electronic systems at the Bern site and the associated processes. The QA electronic systems include SAP QM, EBR (Electronic Batch Release System) and various QA reporting systems (including SAP, Power BI, Statistica).
• Training and qualification of new employees for the QA electronic systems at the Bern site.
• Project management and implementation according to project plans.
• Responsible for master data maintenance of the QA electronic systems at the Bern site.
• Support for inquiries regarding the QA electronic systems and the associated processes within the framework of regulatory inspections.
• Support in the introduction of new/existing products into new markets and in defining the associated business processes.
• Optimization of business processes, especially automation processes for the creation of release documents.
• Creation, review and approval of SOPs in the functional area.
• Collaboration with production areas and many other interfaces.
• Deviation and change management related to QA Batch Release Management and the QA electronic systems.

Qualifications & Professional Experience

• As an ideal candidate, you have completed a degree in natural sciences in the field of pharmacy, biology or chemistry, have several years of professional experience and demonstrate very good knowledge from the industry and GMP environment.
• Good knowledge of SAP QM and reporting systems (SAP, Power BI, Statistica) is an advantage. You convince with high social competence, networked thinking, a careful, structured way of working and decisiveness.
• You are also proactive, set clear priorities and are a personality with good empathy and assertiveness.
• Collaboration with various internal and external parties requires communication skills and customer orientation.
• Very good language skills in German and English (spoken & written) complete your profile.

Do you feel addressed? Then we look forward to your online application. Your application should include a motivation letter, a resume/CV as well as work certificates and copies of diplomas in the original language and/or relevant transcripts

What we offer

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About CSL Behring

CSL Behring is a globally leading company that develops and markets high-quality therapeutics for people with rare and serious diseases. With our medicines for the therapeutic areas of immunology, hematology, cardiovascular and metabolism, respiratory diseases and transplantation medicine, we keep our promise to improve the quality of life of patients in more than 100 countries. Learn more about CSL Behring .

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