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CSV Validation Engineer m/f
Eingestellt von Michael Bailey Associates - Munich
Gesuchte Skills: Engineer, Support
Projektbeschreibung
CSV VALIDATION ENGINEER M/F
Overall Responsibilities:
*Project Quality Support in the CSV Equipment Legacy Review
*Project Quality Support in CSV Equipment Remediation Projects
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
Language Skills:
*English fluent, German
Please contact Frank Arnold for further information.Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Overall Responsibilities:
*Project Quality Support in the CSV Equipment Legacy Review
*Project Quality Support in CSV Equipment Remediation Projects
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
Language Skills:
*English fluent, German
Please contact Frank Arnold for further information.Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Ingenieurwesen/Technik, Sonstiges