Computer Systems Validation Engineer - CSV, Validation

COMPUTER SYSTEMS VALIDATION ENGINEERS - SWITZERLAND

PE Global requires a number of Computer Systems Validation Engineer on an hourly rate contract basis for our client based in Switzerland. Fluent German and/or Italian is preferred. Excellent hourly rates are on offer.

Summary:

-

Working in a remediation project as a CSV Lead for SAP OTC
-

Cover the part of the GxP-Compliance in the project.
-

Creation of the Validation documentation for GxP relevant system elements.
-

Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
- Planning, coordination, execution and reporting of activities related to the project
- The project manager will be providing guidance, project management and reporting activities related to Computer Systems validation remediation activities
-

The person must be analytical, thorough, accurate and proficient in the use of computers
-

Knowledge in MS Project is desired.
-

Background in Quality Systems is required
-

Knowledge of regulation as defined by ISO and FDA is desired - Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11

Please send in your CV for the attention of Neasa O'Connor or Laura Harney or please contact for more information