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CSV Engineer
Eingestellt von Optimus Search
Gesuchte Skills: Engineer, Client
Projektbeschreibung
CSV ENGINEER - SWITZERLAND - 3 MONTHS CONTRACT - €110-€120 PER HOUR
Optimus life sciences are working with a globally known Pharmaceutical company. My client is looking for a CSV engineer to come and work on site for a 3 month rolling contract. You will hit the ground running in this exciting opportunity.
RESPONSIBILITIES:
- Assess proposed new services to assess GxP impact and where GxP impact is identified provide guidance on the risk based approach for the system, working with key stakeholders to achieve business goals.
- Manage all qualification aspects as part of project work, or act as lead role if specific qualification resource has been brought in on the project.
- Manage formal testing of service implementation including identifying and implementing tools, setup of testing, documentation, approval and delivery.
REQUIREMENTS:
- Full understanding and experience in working with Computer System Validation (CSV) and knowledge of FDA 21 CFR part 11
- Familiarity with Infrastructure services including networks, virtualization and storage platforms
- Good understanding of business requirements, high-level solutions and infrastructure components, combined with CSV system experience.
Optimus life sciences are working with a globally known Pharmaceutical company. My client is looking for a CSV engineer to come and work on site for a 3 month rolling contract. You will hit the ground running in this exciting opportunity.
RESPONSIBILITIES:
- Assess proposed new services to assess GxP impact and where GxP impact is identified provide guidance on the risk based approach for the system, working with key stakeholders to achieve business goals.
- Manage all qualification aspects as part of project work, or act as lead role if specific qualification resource has been brought in on the project.
- Manage formal testing of service implementation including identifying and implementing tools, setup of testing, documentation, approval and delivery.
REQUIREMENTS:
- Full understanding and experience in working with Computer System Validation (CSV) and knowledge of FDA 21 CFR part 11
- Familiarity with Infrastructure services including networks, virtualization and storage platforms
- Good understanding of business requirements, high-level solutions and infrastructure components, combined with CSV system experience.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Ingenieurwesen/Technik