Validation and Compliance Expert
Vor 5 Tagen
At Debiopharm International SA, we pride ourselves on being a leader in the biopharmaceutical industry. Our team is dedicated to developing innovative therapies for patients with oncology and infectious diseases, and we are seeking a skilled CSV Senior Officer to join our Quality Management organization in Lausanne.
You will play a vital role in contributing to the development of pioneering treatments in Oncology & Anti-infectives by supporting the Computerized Systems Validation (CSV) Lead in endorsing, maintaining, and facilitating the appropriate compliance level for CSV activities.
Your responsibilities will include:
- Driving compliance excellence with GxP standards and internal quality guidelines.
- Collaborating with the CSV Lead, Business Process Owner, and System Owner to create synergy between business, Quality, and IT.
- Representing Quality during inspections, audits, or other inquiries on CSV matters.
- Overseeing vendor documentation, ensuring vendor compliance.
- Creating and approving CSV deliverables, and ensuring proper filing in document management systems.
To excel in this role, you will need to possess excellent analytical thinking and problem-solving skills, as well as strong interpersonal communication skills.
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Medical Device Validation Expert
Vor 6 Tagen
Lausanne, Waadt, Schweiz ONWARD (GTX Medical) VollzeitAbout the RoleWe are seeking a highly skilled Medical Device Validation Expert to join our team at ONWARD (GTX Medical). In this role, you will play a critical part in ensuring the production and delivery of innovative therapies for individuals with spinal cord injuries.As a Medical Device Validation Expert, your primary focus will be on upholding the...
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System Compliance Expert
Vor 6 Tagen
Lausanne, Waadt, Schweiz B-Hive Switzerland VollzeitB-Hive AG is an engineering company that employs over 900 people worldwide.We are recruiting a CSV Expert who will be responsible for defining a validation strategy and developing an approach to validate systems in compliance with regulations.Key Responsibilities:Develop a validation master plan that outlines project-specific risks and needs.Write key...
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Validation Specialist
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Lausanne, Waadt, Schweiz B-Hive Switzerland VollzeitB-Hive Switzerland is a leading engineering company that has experienced significant growth since its founding in 2017.We are currently seeking a talented CSV Expert to join our team and contribute to the development of our activities in Switzerland.Job Responsibilities:Define a comprehensive validation strategy and develop a clear approach to validate...
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Process Validation Engineer
Vor 6 Tagen
Lausanne, Waadt, Schweiz B-Hive Switzerland VollzeitB-Hive AG is a dynamic and growing engineering company.We are recruiting a CSV Expert who will be responsible for planning and executing validation activities.Key Responsibilities:Develop a validation plan that outlines project-specific risks and needs.Write key validation documents, including URS, protocols, and traceability matrices.Provide expertise to...
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Compliance and Risk Management Expert
Vor 3 Tagen
Lausanne, Waadt, Schweiz NZZone VollzeitAssurance ExpertNZZone is seeking a Compliance and Risk Management Expert to join our Assurance Service Line. As an integral part of our team, you will help us protect and serve the public interest by promoting transparency and supporting investor confidence.The successful candidate will have a strong background in compliance and risk management, with...
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Software Compliance Engineer
Vor 6 Tagen
Lausanne, Waadt, Schweiz ONWARD (GTX Medical) VollzeitAbout the JobWe are seeking an exceptional Software Compliance Engineer to join our team at ONWARD (GTX Medical). In this role, you will play a critical part in ensuring the production and delivery of innovative therapies for individuals with spinal cord injuries.As a Software Compliance Engineer, your primary focus will be on upholding the highest standards...
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Data Validation Specialist
Vor 6 Tagen
Lausanne, Waadt, Schweiz Blackfield Associates VollzeitBlackfield Associates is supporting a global pharmaceutical client in the implementation of a rolling 12-month contract for a Data Validation Specialist. This position involves leading computerized system validation (CSV) for process equipment, facilities, and manufacturing execution systems (MES), ensuring compliance with regulations and driving process...
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Expert Qualification
Vor 5 Tagen
Lausanne, Waadt, Schweiz Efor Group VollzeitL'Efor Group recherche un Spécialiste Qualification et Validation qualifié pour rejoindre notre équipe en Suisse Romande.MissionsEn tant que Spécialiste Qualification et Validation, vous intervenez sur des projets stratégiques liés à l'installation et à la validation d'équipements et de méthodes en environnement laboratoire.Compétences...
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Compliance and Governance Expert
vor 1 Tag
Lausanne, Waadt, Schweiz Intuitive Surgical VollzeitCompany OverviewWe are a global leader in biotechnology based between Geneva and Lausanne. We aim to revolutionize healthcare through innovative technologies.Job SummaryWe are looking for a highly skilled Regulatory Affairs Specialist to join our team. As part of a 9-month project and the launch of a product in the biotechnology market, we require a...
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Regulatory Compliance Specialist
Vor 5 Tagen
Lausanne, Waadt, Schweiz Incyte VollzeitDebiopharm International SA is a Swiss biopharmaceutical company dedicated to researching innovative therapies for patients with oncology and infectious diseases. Our team focuses on developing groundbreaking treatments via our unique business model, acting as a bridge between cutting-edge discovery products and global patient access.We are seeking a CSV...
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Expert Validations Systèmes
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Lausanne, Waadt, Schweiz agap2 Switzerland VollzeitUn poste de travail varié attendra notre prochain collaborateur !Tâches PrincipalesL'Ingénieur en Qualification/Validation assurera la réussite des phases de Commissioning, Qualification et Validation sur des sites de production pharmaceutiques et biotechnologiques :Planifier et coordonner les activités de qualification et validation.Rédiger les...
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Regulatory Compliance Engineer
Vor 6 Tagen
Lausanne, Waadt, Schweiz Blackfield Associates VollzeitThe selected candidate will lead computerized system validation (CSV) for process equipment, facilities, and MES, ensuring compliance and driving process improvements. This is a rolling 12-month contract/freelance opportunity to support a global pharmaceutical client. You will develop and execute CSV documentation for new systems and upgrades, manage...
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Soft Robotics and Aerial Systems Expert
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Lausanne, Waadt, Schweiz NZZone VollzeitWe are a team of experts at NZZone, dedicated to pushing the boundaries of materials science and technology. Our research has real-world applications and contributes significantly to society.We are seeking a talented postdoctoral researcher with expertise in aerial robotics design, control systems, and experimental validation. The ideal candidate will have a...
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Data Integrity Manager
Vor 6 Tagen
Lausanne, Waadt, Schweiz B-Hive Switzerland VollzeitB-Hive Switzerland is committed to excellence and innovation in engineering.We are looking for a talented CSV Expert to join our team and contribute to the development of our activities in Switzerland.Responsibilities:Define a validation strategy that ensures compliance with regulations.Plan and execute validation activities.Develop key validation...
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Qualification & Validation D'Équipements
Vor 5 Tagen
Lausanne, Waadt, Schweiz Efor Group VollzeitEfor recherche un Expert Qualification et Validations qualifié pour rejoindre notre équipe en Suisse Romande.ObjectifsEn tant qu'Expert Qualification et Validations, vous contribuerez à la qualification et à la validation d'équipements et de méthodes en environnement laboratoire.Compétences requisesQualification et validation d'équipements...
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Qualification and Validation Engineer
vor 1 Woche
Lausanne, Waadt, Schweiz Michael Page Switzerland VollzeitNos clients sont en majorité dans le secteur de la santé et spécialisés dans le domaine pharmaceutique, des biotechnologies ou des dispositifs médicaux.Missions- Rédiger la documentation de validation conformément aux processus (URS, analyse de risque, protocole IQ/OQ/PQ, plan de validation, protocole de validation...)- Exécuter tous les tests et...
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Compliance Program Manager
Vor 6 Tagen
Lausanne, Waadt, Schweiz Intuitive Surgical Sàrl VollzeitKey ResponsibilitiesThis role involves several key responsibilities, including:Developing, implementing, and maintaining compliance programs;Providing expert advice and guidance to internal stakeholders;Monitoring and auditing compliance processes;Reporting potential violations to the Group Compliance Committee;Collaborating with cross-functional teams to...
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Compliance and Risk Management Specialist
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Lausanne, Waadt, Schweiz Intuitive VollzeitKey ResponsibilitiesThe Global HCP Compliance Director will have the following key responsibilities:Lead Compliance Programmes Development and ImplementationDevelop, initiate, maintain and revise policies, procedures and best practices to ensure compliance with anti-corruption and transparency legal regulations, and Industry codes of conduct.Provide...
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Senior Compliance Manager
Vor 6 Tagen
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Compliance and Quality Assurance Director
Vor 5 Tagen
Lausanne, Waadt, Schweiz TN Switzerland VollzeitJob Overview:The Compliance and Quality Assurance Director will be responsible for leading the development and implementation of quality systems and compliance initiatives across the organization. This role will oversee the establishment and maintenance of quality policies, procedures, and records, ensuring compliance with regulatory requirements and...