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 

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

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.

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