Quality Systems Expert (d/f/m) 100%
Quality Systems Expert (d/f/m) 100%
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1 Vacancy
Job Description
About Us
Your mission
Your responsibilities will include:
- Maintain adherence to legal regulatory internal company requirements and international quality standards (e.g. EU GMP CFR ICH).
- Guarantee the QMS reflects all legal obligations for medical device manufacturing.
- Lead the development and ongoing management of the pharmaceutical quality system.
- Facilitate customer audits and health authority inspections managing all followup actions.
- Act as the process owner for qualityrelated workflows within the QMS.
- Generate and present key performance indicators for regular Quality Management Reviews.
- Assist in the rollout of a new QMS providing input from a user standpoint.
- Support the efficient handling of documents deviations CAPAs and change requests.
- Serve as the subject matter expert for the Trackwise QMS system.
- Drive enhancements to internal quality processes and manage eQMS administrative tasks.
- Generate actionable insights through comprehensive KPI reporting and analysis.
- Administer and optimize the eQMS platform ensuring system integrity and user access.
- Facilitate the seamless onboarding of new team members fostering a culture of quality and compliance.
Your profile
- Masters degree or equivalent in a science discipline
- 4 years experience in highly regulated pharmaceutical environment preferably inQuality Systems.
- Experience in personal interaction with customers and Health Authority interactions
- Good communication skills
- QA and manufacturing experience preferred
- Business fluency in English is mandatory
- Fluency in German a strong plus
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!
*** No Recruitment Agency only direct applicants***
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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