Description
Senior Computer Systems Validation Specialist - QA /ValidationDescription:
For one of our clients we are looking for an experienced senior validation analyst to support validation activities of a high profile complex project with integrations between external cloud based systems and internal systems. You will be accountable for ensuring that all validation activities, risk assessments and required documentation is addressed across all integrated systems. Additionally, you will be a key point of liaison with the cloud solution supplier's validation lead, as such; they will be responsible for providing guidance to ensure supplier alignment with CSV policies and procedures.
Responsibilities:
- You will support all led validation topics for the Voyager Program (Data Lake, Reporting and Analytics, System Integration, Data Migration)
- You will closely collaborate with the IBM Validation lead to ensure IBM alignment to Client CSV requirements (IBM are responsible for Validation of IBM WPS)
- Collaboration with IBM on preparation of the IBM WPS Validation Plan
- Contribution to preparation and approval of the IBM WPS SRA
- Contribution to preparation and approval of the Data Lake SRA
- Proven track record in validation of complex multi component systems
- Validation of cloud based solutions
Required Skills:
- 8+ years of experience in Validation (e.g. Validation of Lab, Production processes etc.)
- Experience of Adverse Event Reporting / Product Safety
- Solid knowledge of CSV processes
- Experience with validation of cloud solutions
- Knowledge of ICSR Safety Systems especially ARISg
- Experience in Pharma or IT environment
- Knowledge of ICSR Business Process
Education:
- University degree or higher national diploma level equivalent in engineering, preferably in computer science
Languages:
- Excellent English and Communication skills essential
- German (Good to have)
Reference No.: 917445NC
Role: Senior Validation Analyst
Industry: Pharma
Location: Basel und Region
Workload: 100%
Start Date: ASAP
Duration: Till 30.12.2019 (Strong possibility of extension)
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.
Contact us for further information regarding our company, our positions or our attractive payroll-only-program: .
About us:
ITech Consult is a certified ISO 9001:2008 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.