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Senior Scientific Expert Quality Control Specialist

vor 2 Monaten


Bern, Bern, Schweiz Regio X Vollzeit
Job Summary

We are seeking a highly skilled Senior Scientific Expert Quality Control Support to join our team at Regio X. In this role, you will be responsible for supporting the Quality Control activities and projects within our organization, reporting directly to the Manager, Head QC Operation Support.

Key Responsibilities
  1. Develop and maintain product specifications, ensuring timely and professional completion.
  2. Assess and coordinate CSL change requests as a QC assessor/coordinator, demonstrating consistent and professional expertise.
  3. Coordinate QC change requests, generating and editing owned SOPs in a timely and professional manner.
  4. Support QC projects, collaborating with cross-functional teams to achieve project objectives.
  5. Provide administrative support to the QC Ops Manager and departments, ensuring timely and professional delivery.
  6. Support requests from authorities regarding reagents, control, and reference materials, demonstrating expertise and professionalism.
  7. Participate in global projects and cross-site activities, contributing to the success of our organization.
  8. Support the resolution of technical questions or problems regarding batch release, collaborating with colleagues to find solutions.
  9. Capture and edit summarizing QC OOX results, ensuring accuracy and professionalism.
  10. Establish and maintain contacts with global partners, fostering collaborative relationships.
  11. Participate in local and global working groups, projects, initiatives, and task forces, contributing to the success of our organization.
Requirements
  1. Minimum: Bachelor or Technical High School in natural sciences, pharmacy, chemical engineering, or a related field. Alternatively, laboratory technician with well-founded experience in the field of responsibility.
  2. Project management qualification an advantage.
  3. Minimum of 5 years' experience in the pharmaceutical, biotechnology, or related industry with significant exposure to GMP or closely related environments.
  4. Microbiological, biological, chemical, or biochemical analytics in medicinal or pharmaceutical GMP environments.
  5. Fluent German and English language.
About Us

Regio X 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.

We are committed to providing equal employment opportunity for all and encourage you to make your well-being a priority. Learn more about how we care at Regio X.