QA Sterility Assurance (m/f/d)

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.

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

We are looking for someone:

• 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

We offer:

• A valuable and impactful career development opportunity in a 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.

For more information, please read https://www.ten23.health/

If you see yourself in this role, please feel free to contact ​Ms. Amrith Kiran at [email protected]