Beschreibung
For our Pharma client in the Basel area we are looking for a
Computer System Validation Specialist
Description:
Background: We are looking for a senior validation analyst to support validation activities of a high profile complex project with integrations between external cloud based systems and internal systems. Applicant will be accountable for ensuring that all validation activities, risk assessments and required documentation is addressed across all integrated systems. Additionally, the applicant 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 internal CSV policies and procedures. The applicant will have a proven track record in validation of complex multi component systems; validation of cloud based solutions; familiarity with internal CSV policies and processes and knowledge of drug adverse event reporting processes.
Tasks & Responsibilities:
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
You will support the all company 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 CSV requirements (IBM are responsible for Validation of IBM WPS)
Proven track record in validation of complex multi component systems
Validation of cloud based solutions
Must Haves:
8+ years of experience in Validation (eg: Validation of Lab, Production processes etc)
Experience of Adverse Event Reporting/Product Safety
Solid knowledge of CSV process
English Speaking
Nice to Haves:
+++ Experience in Pharma or IT environment
++ German Speaking
Start date: 04.06.2018 (latest start date: 11.06.2018)
End date: 31.12.2019 (+ possible extension)
Location: Kaiseraugst
Are you interested to work in this challenging position? Alessia Biassoli, Talent Resourcer, is looking forward to receiving your complete profile. Please send an e-mail (see below)