Beschreibung
Sehr geehrte Damen und HerrenZur Unterstützung unseres Kunden sind wir auf der Suche nach freiberuflichen Mitarbeitern. Solothurn, Start: ASAP für 12 Monate
Computer System Validation (CSV) Manager
Tasks:
- Planning and implementation of qualification / validation activities and projects of new and existing computer systems according to internal and external requirements for all departments within EMEA
- Advisory and support of application owners to build and maintain GMP conform systems
- Support and consulting during projects handling GxP critical computer systems
- Approving specific computer system validation documentation and acting as software quality assurance
- Development, control and maintenance and of the CSV framework in EMEA
- Definition of the global CSV framework in collaboration with the regional CSV responsibles from US and China
- Approving change requests and monitor the necessary activities for the requalification / validation after changes, deviations, etc.
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
- Developing and performing CSV trainings
- Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.).
Requirements:
- Responsility in similar management position or extended experience as executer required. - Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
- Consultants with approx 5 yrs experience
- English is a must, German would be an advantage.
Bei Interesse, freue ich mich auf Ihre Kontaktaufnahme und Ihren CV, damit wir eine Grundlage für ein Gespräch zur Position haben.
Freundliche Grüsse
Oscar Schröder