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

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'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

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

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.Click on Apply Now! 

For more information and clarification, please connect Amrith ([email protected]) from our Talent team!