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
We're seeking a talented Product Quality Steward to join our dynamic team in Visp, Switzerland, where you'll be instrumental in ensuring the quality and compliance of our innovative products throughout exciting project lifecycles.
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 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.
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
Contact
For more information and clarification, please connect with Amrith (amrith.kiran@ten23.health) from our Talent team!