Beschreibung
Overall Responsibilities:* Project Quality Support in the CSV Equipment Legacy Review
* Project Quality Support in CSV Equipment Remediation Projects
* Team Lead of Site CSV Equipment Team
For my client in Southern Germany, I am looking for a Senior CSV Validation Engineer.
Overall Responsibilities:
* Project Quality Support in the CSV Equipment Legacy Review
* Project Quality Support in CSV Equipment Remediation Projects
* Team Lead of Site CSV Equipment Team
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
* 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
* Leadership skills
A good knowledge of the german language is also required.
Start would be asap for 6 months - full time is required (at least 4 days per week).
Are you available?
Please contact me via
Looking forward to hearing from you.
Regards
Malin Behrens