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 a QC Scientist Qualification and Validation to support our Basel team..
Your responsibilities will include,
- Manage method implementation and validation for QC phys.-chem. analysis on parenteral dosage forms (e.g. (U)HPLC, CE, icIEF, particulate matter and spectroscopy)
- Manage equipment and computerized system life cycle activities in line with guidelines and internal procedures
- Design required documentation for equipment qualification and method validation
- Implement new CSV and qualification guidelines; define and maintain standard working procedures and other quality-related documents for QC equipment life cycle and analytical method life cycle
- Plan and execute tests if needed, support lab personnel in daily activities (testing, training, laboratory management, OOX and deviations)
- Maintain high quality level throughout the workspace
Your profile
We are looking for someone with:
- At least bachelor’s degree or equivalent in a science discipline
- At least 2 years experience in QC equipment qualification, CSV and method validation - must
- At least 2 years' experience in writing QC quality documents (e.g., SOP, analytical test methods, plans, protocols and reports on equipment qualification or CSV and method validation) - must
- At least 3 years GMP experience with a strong affinity to work in a GMP environment – must
- Hands on experience with QC testing for parenteral dosage forms, e.g., CE, LC, compendial methods - preferred
- Experience in managing OOX and deviations under GMP
- Experience with clinical phase projects (early/late stage, or PPQ) desirable
- Experience with electronic Data Integrity principles according to GMP desireable
- Experience with pharmaceutical regulatory inspection and customer audits, nice to have
- Business Fluency in English and German required
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
For more information and clarification, please connect with 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