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Product Quality Steward(m/w/x)

ten23 health
Visp

Du bist der technische QA-Ansprechpartner für Kundenprojekte und stellst sicher, dass während des gesamten Projektverlaufs alle relevanten GMP-Vorgaben eingehalten werden.

Anforderungen

  • •Bachelor's or Master's degree in a related field
  • •Minimum 3 years of hands-on experience
  • •Strong understanding of GMP environment
  • •Experience in sterile pharmaceutical production
  • •Excellent technical teamwork and communication skills
  • •Fluency in German and English
  • •Ability to work independently and efficiently

Deine Aufgaben

  • •Technischer QA-Ansprechpartner in Kundenprojekten sein
  • •Umfassende QA-Überwachung in allen Projektphasen bieten
  • •Produktbezogene Qualitätsunterlagen auf technische Richtigkeit prüfen
  • •Qualitätsvereinbarungsaktivitäten mit Kunden durchführen
  • •Technische Expertise für Methodenübertragungen bereitstellen
  • •Chargendokumente erstellen und prüfen
  • •Technischer Ansprechpartner während Audits sein
  • •Technische Unterstützung bei regulatorischen Einreichungen geben
  • •Chargenherstellung und QC-Freigabe koordinieren
  • •Technische Dokumentation für Kundenprojekte erstellen und genehmigen

Deine Vorteile

Wertvolle Karriereentwicklung
Flexible Arbeitszeiten und Umfeld
Zusammenarbeit mit erfahrenen Mitarbeitern
Vielfältige Schulungsangebote
Wettbewerbsfähiges Pensionsprogramm

Original Beschreibung

## Product Quality Steward (m/f/d) 80-100% ###### Permanent employee, Full-time ·Visp --- ##### 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. * Technically 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. * Technically 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 * Technically own and coordinate the timely and successful batch manufacturing and QC release of all activities related to the product-/customer project * Generate or technically 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 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. ##### 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.
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