QA Qualification Expert (d/f/m) 80-100%
QA Qualification Expert (d/f/m) 80-100%
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1 Vacancy
Job Description
About Us
Your mission
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 requalification and revalidation activities
- Represent QA Qualification during Customer Audits and Health Authority inspections
Your profile
- Masters degree or higher in a life science related discipline
- Experienced in a GMPregulated 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
Heres 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 selfdeveloping culture offers a wide range of training options
- Competitive pension fund plan annual bonus and other financial and nonfinancial benefit
Contact
For more information and clarification please connect Amrith () from our Talent team!
About us
Join Us & Make a Difference! ten23 champions equal opportunity and is committed to diversity and inclusion.
Learn about ten23
Employment Type
Full-Time
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