Beschreibung
CSV SAP Validation Specialist
Edelway AG is a Professional Services Consultancy based in Switzerland. One of our best clients, a global biopharmaceutical company, based in the Bern/Basel area, is currently looking for a CSV SAP Validation Specialist to join them on a long-term basis.
Language: Fluent in English, German is a plus.
Start Date: ASAP
Excellent rate paid per hour.
The role:
Working in a remediation project as a CSV Lead for SAP OTC.
Main Activities:
*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.
Your profile:
*Higher education (Engineer or similar) and background in IT.
*Responsibility in similar position or extended experience as executer required.
*Knowledge of national and international regulations and standards (GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 820, Part 11).
*SAP CSV Experience.
*Team Player.
*Excellent Communication skills
*Quick learner, motivated self-starter.
If this sounds like your next challenge send me your CV and I will call you to discuss the role in more details.