QA Qualification Expert (d/f/m) 80-100%

Permanent employee, Full-time · Visp, Basel

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're seeking a talented and dedicated QA Qualification Expert to join our dynamic team in Visp! If you have a strong background in Quality Assurance within the pharmaceutical industry and a passion for ensuring the highest standards, we want to hear from you.

Your responsibilities will include:
  • Act as main responsible for assigned QA qualification activities
  • Review and approval of design and qualification documents of facilities, utilities and equipment
  • Drive, improve and implement the site qualification activities and respective strategies
  • Participate in the execution of risk assessments (FMEA)
  • Review and approve deviations, changes and CAPAs
  • Act as contact person for maintenance and calibration activities
  • Provide GMP training on Qualification relevant topics
  • Execution of internal audits
  • Provide quality oversight on periodic review, re-qualification and re-validation activities
  • Represent QA Qualification during Customer Audits and Health Authority inspections
Your profile
We are looking for someone with:
  • Master’s degree or higher in a life science related discipline
  • Experienced in a GMP-regulated environment for Drug Product manufacturing or testing
  • Experience in aseptic production
  • Experience in greenfield projects
  • At least 5 years’ experience in QA, Operations, Engineering or CQV
  • Knowledge of relevant GMP regulations (PIC/S, FDA)
  • Familiar with deviation & change processes
  • Experience in Computerized System Validation and/or Process Validation is a plus
  • Proactive and pragmatic quality mindset
  • Business Fluency in German and English
Why us?
We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.
 
Here's what sets ten23 apart:
  • 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
Click on Apply Now! 

For more information and clarification, please connect Amrith (amrith.kiran@ten23.health) from our Talent team!
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
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