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Reference # :
19-00067
Title :
Experienced CSV Consultant
Location :
Switzerland
Position Type :
Permanent / Festanstellung@wega
Experience Level :
Start Date :
01/10/2019
Description
We are a Life Science and IT service provider that has been successfully carrying out 'state-of-the- art' projects for international customers since more than 25 years. Our consultants work in
our offices in Basel
sometimes in Home-Office
sometimes in our customer's premises.
We pride ourselves on being a dynamic forward thinking organization. We are looking for like-minded individuals with ambitions and highly motivated by interesting jobs, as well as financial incentives. Are you ready for the next step and challenge in your career? Do you enjoy working in an environment that values it´s employees? If yes, then it is probably the right time to move on and apply for a permanent Job @wega.
Main tasks:
Act as a CSV consultant in various IT projects in Switzerland/Germany for customers in the pharma industry.
Responsible for writing, reviewing and approving the needed documents in accordance to the customer QMS and regulatory
Support/Moderate Risk assessment sessions to help identifying risks associated to an IT system and support/monitor execution of associated mitigations.
Support testing, documentation and change management activities.
Interact with all project stakeholders (Business Owner, System Owner, Test Team) as a central project member.
Qualification and Experience:
More than 3 years experience in SW Quality Management, SW Testing, CSV or another quality assurance area within a regulated industry.
General knowledge of GxP, 21CFRPart11, Annex 11, GAMP5. Experience in other regulated domain(s) accepted as well.
Excellent communication skills, very good written and spoken English and German
Willingness to travel (up to 30%)
Experience with Test Management Tool(s) is a plus (e.g. Client ALM)
