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
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##### 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.