Beschreibung
Risk Advisory - Life Science Advisory, Senior Manager (FDA21;CFR PART11; GLP;GCP;GDP)
Job content
Our Risk Advisory team is looking for you!
Our Risk Advisory experts advise customers how to manage technological, operational, financial and business process risks. Is risk and regulatory advisory your passion?
Then we're the right company for you.
Deloitte offers you national and international career opportunities as well as a broad internal and external training programme.
What you can expect from us
We offer you a varied and challenging role in a quickly growing company.
You will handle business and IT consulting projects on client's site and analyse the requirements on business side.
You will support/moderate Risk assessment sessions to help our clients identify risks associated to an IT system and support/monitor execution of associated mitigations.
You will conduct testing, documentation and change management activities.
You will gain in-depth complex business processes and system environment expertise.
You will manage business development activities.
As a member of our highly motivated, multicultural team, you can expect new challenges every day.
Requirements
Master's degree from a university or technical college in Computer Sciences or Natural Sciences
Extensive experience in Computer Systems Validation projects
Knowledge of the FDA 21 CFR Part11, regulations and guidelines (GLP;GCP:GDP etc)
Understanding of Quality Risk Managemen
Experience in User Requirement Specification (URS) and testing
Handling of product category 3, 4 & 5 from specification to verification under GAMP5Design/Installation/Operation/Performance Qualification (DQ, IQ, OQ, PQ)
Enthusiasm for new ideas and innovative solutions.
You find working with various stakeholders, daily challenges and exciting projects rewarding.
You are happy to travel in the area of Switzerland and EU.
You communicate confidently in German and English. Any further languages would be an advantage.