Auf einen Blick
- Aufgaben: Sichere die Qualität von Produkten und arbeite eng mit externen Partnern zusammen.
- Unternehmen: Internationale Pharmafirma in Neuchâtel mit einem dynamischen Team.
- Vorteile: Hybrid-Arbeitsmodell, wettbewerbsfähiges Gehalt und Entwicklungsmöglichkeiten.
- Weitere Informationen: Tolle Karrierechancen in einem internationalen Umfeld.
- Warum dieser Job: Gestalte die Qualität von innovativen Produkten und mache einen echten Unterschied.
- Qualifikationen: Abschluss in Pharmazie oder verwandten Bereichen und Erfahrung in der Qualitätssicherung.
Das prognostizierte Gehalt liegt zwischen 85500 - 104500 CHF pro Jahr.
- Location: Neuchâtel, Switzerland
Typ
Quality Assurance Engineer - Location: Neuchâtel, Switzerland
Type of contract : Temporary - 1 year - Work
- Model: Hybrid (50% remote)
Languages: Fluent English required - German is a plus - French is not required for this position
Eligibility: Valid Swiss work permit or Swiss nationality required
About the Opportunity
Our partner, an international pharmaceutical company based in Neuchâtel, is looking for a QA Specialist to join its Quality Assurance team.
This role focuses on QA Vendor Oversight, ensuring that products manufactured by external partners comply with GMP requirements and global quality standards.
You will act as a key quality contact for contract manufacturers, supporting batch release activities, investigations, change controls, supplier quality management, and compliance initiatives.
Key Responsibilities
Manage Quality Assurance activities related to external manufacturing partners and CMOs.
Maintain strong working relationships with contractors and quality representatives.
Lead discussions on quality topics including deviations, change controls, complaints, OOS investigations, and CAPAs.
Review and approve quality documentation, validation protocols, validation reports, investigations, and change controls.
Prepare and review Batch Release Packages to support final product disposition.
Support product release activities while ensuring GMP and regulatory compliance.
Manage and assess change controls, including QA approval and impact evaluation.
Support complaint investigations and vendor-related quality issues.
Review Process Validation and Technology Transfer documentation.
Participate in Annual Product Quality Reviews (APQR/PQR).
Draft, review, and manage Quality Agreements with external partners.
Participate in supplier audits, self-inspections, and regulatory inspections.
Maintain quality metrics, trend analyses, and quality databases.
Contribute to the continuous improvement of Quality Systems.
Author and review SOPs, work instructions, and quality procedures.
Support GMP and GDP compliance activities across the organization.
Profile
Bachelor's or Master's degree in Pharmacy, Biotechnology, Chemistry, Life Sciences, or related field.
1 to 4 years of experience in Quality Assurance within a GMP-regulated pharmaceutical or biotechnology environment.
Fluent English (written and spoken) is mandatory - German is a plus
Good understanding of GMP, GDP, and pharmaceutical quality standards. jpideae855fws jpit0835ws jpiy26ws
Quality Assurance Specialist Arbeitgeber: Gi Life Sciences
Notre entreprise, située dans le canton de Neuchâtel, se distingue par un environnement de travail collaboratif et dynamique, où chaque employé est valorisé et encouragé à développer ses compétences. Nous offrons des opportunités de croissance professionnelle grâce à des formations continues et un soutien constant, tout en garantissant un équilibre entre vie professionnelle et personnelle. Rejoindre notre équipe, c'est faire partie d'une culture d'excellence et d'innovation, où votre expertise en métrologie sera essentielle pour assurer la qualité et la conformité de nos équipements critiques.
