CSV (computer systems validation) Expert
CSV (computer systems validation) Expert
Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across a number of professional sectors, with IT being at the heart of our operations.
For one of our clients, specialized in the pharmaceutical area with HQ in Basel, we are looking for a Computer Systems Validation Expert with experience in Software Development Lifecycle.
This is a challenging contracting position starting in October until the end of 2020 with extension possibilities.
Tasks & Responsibilities:
- Drive the move to an agile regulatory framework
- Create or support the creation of project-based documentation for computerized systems validation:
- Create risk assessments, validation plans and reports.
- Write functional specifications
- Deliverables of the Specify and Design Phase
- Registry list
- Responsible for reviewing (formally or informally) CSV deliverables:
- Review design specs and make sure they cover requirements
- Review System Test + UAT scripts, liaise with test team
- Responsible for monitoring CSV deliverables (all project phases)
- Lead and coordinate testing activities:
- Plan and monitor SAT and UAT with testers and users
- Support and coordinates SAT and UAT, as required
- Review executed SAT and UAT, management of the deviation log
- Ensure requirements traceability
- Support IT and Quality while discussing CSV strategy
- Providing validation and Compliance advice and guidance to project managers and project team
Requirements:
- +7 years of experience with computer systems validation (CSV) projects and all related deliverables
- +7 years of experience with computer system and device qualification
- Extensive technical background e.g. +10 years' experience in the Informatics/Information Management area) and Software Development Lifecycle
- Experience with HP ALM, Jira and confluence
- Flexible and able to work on several tasks in parallel
- Team player with very good communication skills
- Excellent written and spoken English language skills
- Experience in the Pharmaceutical industry
Location: Basel
Start Date: 21.10.2019
End date: 31.12.2020
Extension: possible
Work location: Basel
Workload: 100%
Remote/Home Office: possible 1 day per week
Travelling: Some business trip
If you are a result-oriented CSV Expert currently looking for a challenging new position that applies to your skills, then we look forward to receiving your application!
Not the right job for you? Since new jobs are coming in every day just give us a call +41 (0)61 282 22 17. Experis, the leading IT recruitment agency in Switzerland has many open jobs, just browse our website now to find interesting professional opportunities!
