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Open nowPosted 1402 days ago

QA Product Lead, Visp e/v/e/r/y/o/n/e

ten23-health15 open roles

Where
Visp
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Your applicationOpen nowQA Product Lead, Visp e/v/e/r/y/o/n/eten23-health · Visp

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Share of postings closed within
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  2. 4.6%3 days
  3. 13.3%7 days
  4. 21.3%14 days
  5. 35.7%30 days
  6. 59.1%60 days
This job: posted 1402 days ago

The posting

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 tomorrow’s 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 Leads to join us in 2027 and 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 libraries,etc. ensuring technical accuracy and GMP compliance.

Your profile

We are looking for someone with:

  • Bachelor's or Master's degree in Biochemistry, Biotechnology, Pharmacy, or a closely related technical field.
  • Minimum 8 years of hands-on experience in a relevant technical QA role.
  • Experience in Drug Product manufacturing, aseptic operations is ideal
  • 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.

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.

Contact

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

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