Experienced Csv Consultant
Vor 4 Tagen
We are a Pharma and Life Science IT service provider that has been successfully carrying out 'state-of-the-art' projects for international customers for more than 28 years, now. Our consultants work in
- our office in Basel
- from home
- on our customer’s premises
We are a dynamic forward-thinking and expanding organization with a great team spirit and always on the look out for like-minded individuals. If you are driven by ambition and highly motivated by challenging jobs, as well as financial incentives, you have come to the right place.
With our attractive compensation and fringe benefits model, this is a great opportunity to maximize your earning potential. The further development of our colleagues and team members coupled with an excellent work atmosphere are amongst the top values of our company.
**Your Areas of Responsibilities**:
- 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.
**Your 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)
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