About Us
ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.
Your mission
We are looking for
QA Sterility Assurance to support our Visp team….
Your responsibilities will include:
- Drive the contamination control strategy in alignment with Annex 1
- Provide strategic guidance on how to execute and improve our Aseptic Process Simulation (APS) strategy. Verify by reviewing and approving APS protocols and records
- Assess and implement improvement activities related to APS, including training of operators
- Define Environmental Control strategy for an ongoing investment project into a new aseptic manufacturing line
- Take a leading role in defining our hygiene concept including in close collaboration with manufacturing department
- Act as QA leader for our disinfectant and pest control programs
- Review and assess semi-annual trending reports from QC related to critical microbiological and chemical/physical process parameters. Drive resulting improvements.
- Review and approve Environmental Monitoring reports related to batch release
- Review Regulatory dossiers for compliance related to microbiological topics
- QA for QC related activities like specification and method related document review and approval, review submission of QC part
Your profile
We are looking for someone with:
- Bachelor degree or higher in Microbiology or proven relevant experience in Microbiology
- At least 5 years’ experience in aseptic drug product manufacturing and aseptic process simulations
- Profound GMP knowledge in all relevant national, EU and US regulations
- Familiar with deviation & change process
- Additional experience in Quality Control is a plus
- Business Fluency in German and English
Why us?
We offer:
- A valuable and impactful career development opportunity in an inspiring environment
- Flexible working arrangements and environment with an open culture and diverse workforce
- The opportunity to work with and learn from highly qualified and experienced employees
- Our learning and self-developing culture offers a wide range of training options
- Competitive pension fund plan, annual bonus, and other financial and non-financial benefit
At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws.
Contact
About us
While most applicants fall short of 100% qualifications, we embrace diverse perspectives and encourage applications from all qualified candidates, regardless of background. Women & underrepresented groups, we see you!
Join Us & Make a Difference! ten23 champions equal opportunity and is committed to diversity and inclusion.
Learn about ten23,
https://www.youtube.com/watch?v=HgS3wd03JV0
