Beschreibung
For my client a leading Medical Device company based in Solothurn we are looking for a
CSV Lead for SAP OTC
Overall Responsibilities:
- Working in a remediation project as a CSV Lead for SAP OTC.
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
Requirements:
- 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 CFRPart 820, Part 11
- SAP CSV Experience
- Team Player
- Excellent Communication skills
Language Skills: English fluent, German is a plus
This is a WORKER Role.
ACTUAL WORK LOCATION: Zuchwil, SO, Switzerland
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, German is a plus
CSV Lead for SAP OTC Remediation Project, Senior Level with Leadership skills preferred.
Experience in SAP Validation is a must.