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.
Capabilities
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. HP ALM)
Role
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.
Capabilities
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. HP ALM)
Bewerben Sie sich direkt mit ersten Informationen oder Links wie z.B. zu ihrem Profil bei LinkedIn über das untenstehende Formular, oder über folgende E-Mail Adresse: jobs@wega-it.com
