Beschreibung
Reference Nr.: 4780JK
Industry: Pharmaceutical
Location: Basel und Region
Start: ASAP
Duration: 6 months
Role: Support Managers to ensure that all aspects of global and local Computerized Systems comply with regulatory requirements and the related Quality Manual.
Specifically:
o Ensure that Data Integrity is maintained throughout the business process.
o Ensure that programming and validation procedures comply to the requirements of the Corporate Quality Manual.
. Review, evaluation, and approval of Computerized System related quality concepts, plans and documents of divisional and local projects and applications.
. Oversee QA operations for computerized systems validations and change control.
. Review/approve validation deliverables for global computerized systems in the QA role.
Requirements: Education:
Graduate in Pharmacy, natural sciences or information technology or several years of equivalent experience in pharmaceutical or related industry
Experience:
. pharmaceutical experience is a MUST
. Experience in Quality Management Departments or equivalent Consultant positions with excellent knowledge of computerized system validation aspects and
. Good experience with Quality Management and Computerized Systems Validation aspects of application implementations and operations (eg Clinical Data Management Systems, ERP/SAP, DMS, LIMS) in the regulated Pharmaceutical Industry.
. Knowledge in scientific and clinical data management and statistical programming is an advantage
- Fluent spoken and written English is a must; German is a plus