IT/QA Project Manager in Geneva

veröffentlicht:
Ort
Geneva, Genf
Sektor
Life Sciences
Jobtyp
Contract
Referenznummer
8212
Kontakt
Coralyne Saint-Cirel, Geneva Professionals Health Care & Life Sciences
Telefon
058 201 54 40
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Stellenbeschreibung

Key responsibilities and accountabilities:

·         Implementation of an existing electronic Document Management System

·         Establish the User Requirements Specifications with different users of the existing electronic Document System

·         Establish of Functional/Design Specifications with IT and the Suppliers

·         Write and Perform IQ/OQ/PQ and tests and issue the IQ/OQ/PQ reports and final qualification report

·         Write the SOPs (access control, backup & recovery, specific use of system, system administrator) with different users

·         Organize and train the users on the use of the system and the SOPs for the go-live

·         Support the organization at the start of the go-live

Skills and competencies:

·         Previous experience in IT Quality in a regulated pharmaceutical or biotechnological environment

·         Practical working knowledge of GLP/GCLP and all related EU & FDA regulatory requirements and ICH guidelines

·         Ability to work effectively in team, and work independently and in multi-cultural environment

·         Ability to take a pragmatic approach to problem solving

·         Good verbal and written communication in English and in French

·         Excellent interpersonal skills

·         Practical knowledge of Computer system validation

·         Swiss resident or EU national

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