It Quality System Support (Gxp)

Job Description We are seeking highly IT Quality System Support to join our team as consultants for a leading global pharmaceutical company.  Main Tasks: • Review and compliance sign off for SLC activities related to IT infrastructure qualification and validation of application systems used in IT (e.g.
change control, risk assessment, configuration and installation testing, functional and requirement testing, periodic review, exception monitoring, etc.)
thus ensuring all deliverables meet regulatory requirements, including computer systems validation, electronic records, data integrity and signature requirements • Advise/consult System Leads and teams in creation and execution of IT changes • Monitor adherence to Corporate IT Regulations Requirements Fluent in written and spoken English Master's degree in computer science Solid experience with quality management systems (e.g.
GAMP) and IT standards (e.g.
ITIL) In-depth knowledge of the regulatory environment (e.g.
GxP, audits) and information technology In-depth knowledge of GxP-relevant IT processes and their support by computerized systems Excellent communication skills, analytical thinking and the ability to work in a spirit of partnership Ability to build consensus and influence decisions