QA Release Specialist

CSL Behring is a leading global biotech company committed to its promise to save lives. In Bern, with over 1'600 employees, we develop and distribute life-saving therapies for people with severe and rare diseases worldwide. For our Quality Assurance team in Lengnau, we are looking for a committed personality as QA Release Specialist (100%) - (m/f/d) By arrangement. In this versatile role, you will take responsibility for batch release activities for the Swiss market, support compliance with regulatory requirements in the GDP environment, and actively contribute to the continuous development of our quality management system. Competencies and responsibilities • Execution and coordination of QA batch release activities for the Swiss market in compliance with applicable GMP and GDP requirements. • Review and approval of batch documentation as well as ensuring timely product release in cooperation with internal and external stakeholders. • Support of the quality management system through the processing of changes, deviations, CAPAs, as well as the maintenance and further development of SOPs and quality-relevant documents. • Participation in the qualification and monitoring of distributors as well as ensuring compliance with regulatory requirements in the GDP environment. • Support during regulatory inspections (e.g., Swissmedic), internal audits, as well as during the preparation and follow-up of regulatory inspections. • Participation in product launches as well as support in the implementation of new quality and release processes. • Close cooperation with the QA Release teams in Lengnau and Bern as well as with other national and international interfaces. • Taking over the deputy role for the team lead after appropriate training, as well as gradual assumption of additional professional responsibility. Qualifications and professional experience • Completed Bachelor's or Master's degree in pharmacy, chemistry, biology, biotechnology, or a comparable scientific field. • Ideally initial professional experience in a GMP-regulated environment, preferably in the area of QA Release, Batch Release, or Quality Assurance within the pharmaceutical industry. • Knowledge of GMP requirements; experience in the GDP environment or in the area of distribution is an advantage. • Understanding of regulatory requirements as well as interest in quality systems, compliance, and product release processes. • Strong communication skills, openness, and enjoyment of cross-departmental cooperation. • Independent, structured, and flexible way of working as well as willingness to take on responsibility. • Fluent German and English skills in spoken and written form. Do you see yourself in this position? Then we would be happy to receive your CV, your employment references, and your diplomas as an application. CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.