- Gérer les processus de V&V (Vérification and Validation) des équipements et de fabrication (emballage, transports...)
- Mener des validations et rédiger les rapports de qualifications (IQ, OQ, PQ)
- Gérer le processus de Conception et Développement
- Gérer le Processus de « Risk Management » en collaboration avec tous les départements
- Conduire de nouveaux projets avec la Direction pour la mise sur le marché de dispositifs médicaux classe III
- Participer à la gestion des Dossiers Techniques en collaboration avec le responsable des Affaires Règlementaires
- Participer aux audit externes
- Participer à des audits internes
- Collaborer avec la Qualité dans le suivi des CAPA
- Participer à l'amélioration continue des processus de fabrication ainsi que de la qualité des produits
- Participer à l'animation de formations internes
- Minimum 2-3 ans de pratique dans un poste similaire
- Expérience en validation obligatoire
- Bonne maîtrise des aspects légaux, réglementaires et normatifs dans le domaine des dispositifs médicaux (ISO 13485, ISO 14971, directive 93/42/ECC et du règlement (UE) 2017/745 relatif aux dispositifs médicaux (RDM)
- Diplôme d'ingénieur ou équivalent, idéalement dans un domaine scientifique, mécanique ou de la santé
- Langue française et anglaise obligatoires, espagnol et/ou allemand un atout
-
Manager Validation
vor 1 Woche
Michael Page Switzerland Bern, SchweizNotreclient est une entreprise internationale spécialisée dans ledéveloppement de dispositifsmédicaux. · Informations surl'entreprise · Entreprise internationale · Dispositifs médicaux · Missions · Gérer les processus de V&V (Vérification andValidation) des équipements et de fabr ...
-
Computer System Validation Manager
vor 4 Tagen
Galexis Niederbipp, SchweizNiederbipp · - Galexis AG · - IT · **Das kannst du bewirken**: · - Zentrale Ansprechperson für Projekte und Änderungsvorhaben für GxP-relevante Applikationen · - Planen, Konzipieren und Durchführen von risikobasierten Validierungsvorhaben sowie die fristgerechte Erstellung der da ...
-
Computer System Validation Manager
vor 4 Tagen
Galexis AG Niederbipp, SchweizNiederbipp · - Galexis AG · - IT · **Das kannst du bewirken**: · - Zentrale Ansprechperson für Projekte und Änderungsvorhaben für GxP-relevante Applikationen · - Planen, Konzipieren und Durchführen von risikobasierten Validierungsvorhaben sowie die fristgerechte Erstellung der da ...
-
Office Manager
vor 1 Tag
Adecco Bern, SchweizDie Adecco Gruppe Schweiz ist Schweizer Marktführer im Bereich Human Resources. Mit über 600 Mitarbeitenden an über 50 Standorten in allen Sprachregionen verhelfen wir jährlich rund 23'000 Fachkräften zu neuen beruflichen Herausforderungen. Unsere Marken sind in ihrem jeweiligen ...
-
Branch Office Coordinator
vor 1 Stunde
Adecco Bern, SchweizDie Adecco Gruppe Schweiz ist Schweizer Marktführer im Bereich Human Resources. Mit über 600 Mitarbeitenden an über 50 Standorten in allen Sprachregionen verhelfen wir jährlich rund 23'000 Fachkräften zu neuen beruflichen Herausforderungen. Unsere Marken sind in ihrem jeweiligen ...
-
Sachbearbeiter in Personalmanagement
vor 1 Tag
Adecco Bern, SchweizDie Adecco Gruppe Schweiz ist Schweizer Marktführer im Bereich Human Resources. Mit über 600 Mitarbeitenden an über 50 Standorten in allen Sprachregionen verhelfen wir jährlich rund 23'000 Fachkräften zu neuen beruflichen Herausforderungen. Unsere Marken sind in ihrem jeweiligen ...
-
CSL Behring Bern, SchweizWe are currently looking for a · **Commissioning & Qualification Center of Excellence (CoE) Strategy Lead**: · The Commissioning & Qualification (C&Q) Center of Excellence (CoE) Strategy Lead role leads the overall execution of the commissioning, qualification and validation effo ...
-
Csv Consultant
vor 1 Woche
Experis Bern, SchweizCSV Consultant · **Experis is the global leader in professional resourcing and project-based workforce solutions.** · **For our client, a leading Pharmaceutical company in Bern, we are looking for a CSV Consultant.** · **Location: Bern** · **Duration of contract: 9 months** · **R ...
-
Quality Assurance Architect 20624-1
vor 5 Tagen
We make it GmbH Bern, SchweizWe make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. · Concentration of placement activities on the core areas of industry, technology, office/administration, ...
-
Onsite Scanning/ Ap Resource
vor 2 Tagen
Experis Bern, Schweiz**Onsite Scanning / AP Resource** · *** · Experis is the world's leading provider of professional staffing and project-based workforce solutions. · **Contract Overview** · On behalf of our client, a leading financial services company in Bern, we are looking for an Onsite Scanning ...
-
Cqv Leads
vor 1 Woche
Project Delivery Partners Bern, SchweizJob Summary · PDP is a number one CQV Project Partner in Switzerland. We have ongoing requirements in Switzerland, and other European locations. We are actively interviewing CQV Leads who have strong knowledge and experience of Upstream / Downstream / Clean /Black Utilities / Sup ...
-
Analytical Development
vor 1 Stunde
ALTOGEN AG Bern, SchweizALTOGEN is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. · With several years of experience, technical expertise and project coordination, we support our partners throughout all ar ...
-
Analytical Development
vor 1 Woche
ALTOGEN AG Bern, SchweizALTOGEN is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. · With several years of experience, technical expertise and project coordination, we support our partners throughout all ar ...
-
Head of Chemistry Manufacturing and Controls
vor 2 Tagen
CSL Behring Bern, SchweizThe Head of Chemistry Manufacturing and Controls (CMC) Strategy Office is responsible for two major functions: · 1 - acting as a CMC Lead for one or more PPD CMC projects · 2 - overseeing the CMC Strategy Office and Portfolio Management capabilities/resources within PPD. · Both e ...
-
Commissioning and Qualification Lead
vor 1 Tag
Capgemini Engineering Kanton Bern, Schweiz**About us**: · **World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the re ...
-
Warehouse Operator
vor 4 Tagen
Techfirm Industrial Services Bern, SchweizFor our _**Techfirm Industrial Services**_team, we would like to integrate a · **Warehouse operator (M/W/D)** · ready to join us in Switzerland to take up new challenges together · **WHAT WILL BE YOUR TASKS** · - Performs and documents daily Weigh & Dispense operations and intern ...
-
Manager, Commissioning
vor 1 Tag
Emergent Biosolutions Bern, SchweizPurpose of this role Ensure efficient qualification processes under the currently applicable requirements and recognized industry best practice Management of the qualification team (Functional and personnel ) · To complement and strengthen our Engineering Department we are lookin ...
-
Capex Project Manager
vor 1 Stunde
Adecco Bern, SchweizWe are looking to recruit a CapEx Project Manager for one of our clients in the manufacturing sector in the area of Bern. · **CAPEX Project Manager**: · **Your challenges** · - Overview of a wide range of activities across the organization, such as development, procure, construct ...
-
QA Commercial
vor 1 Woche
Techfirm Industrial Services Bern, SchweizFor our _**Techfirm Industrial Services**_ team, we would like to integrate a · **QA commercial (M/W/D)** · ready to join us in Switzerland to take up new challenges together · **WHAT WILL BE YOUR TASKS** · - Offer immediate support to operations and quality control teams to addr ...
-
Postdoc/phd Student
vor 2 Tagen
Universität Bern Bern, SchweizThe Vetsuisse-Faculty from the University of Bern, Switzerland is looking for a POSTDOC / PhD student (100%) starting 1st of July 2024 or earlier for the project: 'Swiss Vettriage System' - teletriage for animals. · This pilot project will establish the prerequisites for a veteri ...
Manager Validation - Bern, Schweiz - Michael Page
Beschreibung
Une activité variée, passionnante et pleine de défis dans une entreprise à taille humaine.