Beschreibung
Qualification and Validation Engineer 80
CSV+Validation+German+GxP+GAMP5+ISO+Medical Devices
Location: Zuchwil
Title: CSV VALIDATION ENGINEER
Language Skills: English fluent, German is a plus
Overall Responsibilities:
- Project Quality Support in the CSV Remediation Project
- Project Management & Leader Skills
- Experience in SAP related validation activities.
Tasks:
- Cover the part of the GxP-Compliance in the project.
- Creation of the Validation documentation for GxP relevant system elements
- Support in the creation of 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
Requirements:
Higher education (Engineer or similar) and background in IT
- Experience 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
- CSV Experience in the area of Medical Devices Manufacturing
- Team Player
- Excellent Communication skills
Non-Technical profile requirements: - Some flexibility in working hours is required - Must be able to work on multiple simultaneous tasks with limited supervision; - Quick learner, motivated self-starter; - Excellent customer service, interpersonal, communication and team collaboration skills; - Able to follow change management for internal guidelines. Language proficiencies: -English spoken and written;