Description
I'm currently looking for a CSV (Computer Systems Validation) Project Manager for a remediation project in Switzerland.Start: Immediate - 19.12.2014
Location: Solothurn Canton, Switzerland
Overall Responsibility:
- Working in a remediation project as a CSV Lead for SAP.
Tasks:
- 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
Extended Duties:
- Planning, coordination, execution and reporting of activities related to the project
- Leadship for the QA Sub Project Team
Requirements:
- Experience in the Pharma / Medical Devices Industry
- Higher education (Engineer or similar) and background in IT
- Responsility 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 CFRPart 820, Part 11
- SAP CSV Experience
- Team Player
- Excellent Communication skills
- Fluent English (Must Have) ; German (Nice to Have)
Have I captured your interest? Please forward your resume and all inclusive rate to my e-mal address: I will get in touch with you in regards to the application process after going through your documents.