QA Qualification Expert e/v/e/r/y/o/n/e

About the role

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. 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 We are looking for someone with: 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 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. Click on Apply Now! For more information and clarification, please connect Amrith (amrith.kiran@ten23.health) from our Talent team!

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