Beschreibung
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, for Mezzovico site Italian fluent
Location - Zuchwil, Solothurn, Grenchen, Bettlach, Mezzovico, Raron, Haegendorf, Balsthal, Waldenburg
Bei Interesse und wenn Sie nachweislich in den letzten Projekten in diesem Umfeld gearbeitet haben, freuen wir uns über die Zusendung Ihres aussagekräftigen Profils/CV/Projektliste im Word-Format.
Sollten Sie selber nicht verfügbar sein, können Sie diese Stellenbeschreibung auch an befreundete Kollegen weiterleiten.
Für Rückfragen stehe ich Ihnen gerne telefonisch zur Verfügung.
Viele Grüße
Frank Arnold
Pharmaceutical Recruitment Consultant
Michael Bailey International is acting as an Employment Business in relation to this vacancy.