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Product Quality Steward, Visp everyone
Product Quality Steward, Visp everyoneten23 health AG • Visp, Valais, Switzerland
Product Quality Steward, Visp everyone

Product Quality Steward, Visp everyone

ten23 health AG • Visp, Valais, Switzerland
Il y a 4 jours
Description de poste

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 tomorrows medicines. We support our clients in developing differentiated stable usable and safe injectable treatments for patients.

Your mission

Join our Quality Leadership Team in Visp Switzerland!

We are looking for two QA Product Quality Stewards to drive excellence across our project lifecycles. If you are a technical QA specialist who enjoys being the go-to person for customers and internal teams alike this is your next move.

Your responsibilities will include

  • Act as the primary technical QA representative and point of contact in customer projects addressing all quality-related technical inquiries and providing expert technical input.
  • Provide comprehensive technical QA oversight and support throughout all phases of customer projects ensuring adherence to relevant GMP and regulatory technical requirements.
  • Contribute to review and critically assess product-related quality records (DEV CAPA CR) for technical accuracy completeness and compliance.
  • Executing Quality Agreement activities with the customers
  • Provide technical expertise and support method transfer as well as specific qualification verification and validation activities in collaboration with other QA disciplines to ensure technical robustness and regulatory compliance.
  • Issue batch records (including labels) and provide in-depth technical support for batch record review for any product-related batch documentation.
  • Serve as a technical SME during customer audits and health authority inspections
  • Provide technical input and support for regulatory submissions related to customer projects working closely with Regulatory Experts
  • Own and coordinate the timely and successful batch manufacturing and QC release of all activities related to the product- / customer project
  • Generate review and approve a wide range of critical customer project-related technical documentation including product-specific SOPs Master Batch Records specifications sampling plans and defect librariesetc. ensuring technical accuracy and GMP compliance.

Your profile

We are looking for someone with :

  • Bachelors or Masters degree in Biochemistry Biotechnology Pharmacy or a closely related technical field.
  • Minimum 3 years of hands-on experience in a relevant technical QA role.
  • Strong understanding of and proven ability to thrive within a GMP environment with experience in sterile pharmaceutical production being a significant advantage.
  • Excellent technical teamwork and communication skills with a proactive approach to contributing ideas and a genuine enthusiasm for shaping the future of our QA function (technical experience in microbiology and QC is a plus!).
  • Fluency in both spoken and written German and English to facilitate effective technical communication.
  • Ability to work independently and efficiently on technical tasks while also recognizing and valuing the importance of seamless cross-functional technical collaboration.
  • Why us

    We offer a dynamic environment where you can contribute meaningfully collaborate with exceptional minds and unlock your full potential.

    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 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 () 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

    Key Skills

    Digital Marketing,Marketing,Google Analytics,Growing Experience,Conversion Optimization,Google AdWords,Hybris,Magento,Account Management,SEO,E-Commerce,Analytics

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

    Créer une alerte emploi pour cette recherche

    Product Quality Steward Visp everyone • Visp, Valais, Switzerland

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