Job Description

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 and dedicated QA Qualification Expert to join our dynamic our QA Engineering team in Visp! If you have a strong background in Quality Assurance within the pharmaceutical industry and a passion for ensuring the highest standards, we want to hear from you.

Your responsibilities will include:

• QA Oversight for the qualification of facilities, utilities, equipment and systems
• Coordinates on-site qualification activities, review and approval of qualification documents.
• Ensuring the timely execution of requalifications according to QMP.
• Review and approval of all qualification documents (URS, GMP RA) & Plans and Reports for DQ/IQ/OQ/PQ)
• Management of Incidents, deviations within the scope of qualification activities, management of pending items
• Driving implementation the qualification strategy and being a strong decision maker when needed
• Ensuring compliance with regulatory as well as in-house requirements and quality standards.
• Evaluates and approvals of technical change requests during the different phases of a project and lifecycle and their relevance to the qualification of facilities, equipment, utilities and systems
• Contact person for maintenance-specific questions (change logs, maintenance database and calibration strategy).
• Preparation and timely release of the maintenance / qualification report after shutdown.
• Representing qualification topics during customer audits and regulatory inspections

Your profile

• University degree in a natural science or engineering field (Pharmacy, Biotechnology, Engineering, Chemistry, or any related field
• Significant experience in the pharmaceutical industry, ideally in an Annex 1 regulated environment
• Experience with Qualification of Major Equipment is a plus
• Good understanding of the applicable cGMP regulations
• Experience in quality assurance, MSAT, or pharmaceutical operations
• Good knowledge of engineering and manufacturing processes
• Ability to oversee project execution to identify non-compliance from quality standards
• Good language skills in German and English required

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

Click on Apply Now!

For more information and clarification, please connect Amrith (amrith.kiran@ten23.health) from our Talent team!