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CSV Validaton Engineer
Eingestellt von Michael Bailey Associates - Munich
Gesuchte Skills: Engineer, Support
Projektbeschreibung
CSV VALIDATION ENGINEER
OVERALL RESPONSIBILITIES & TASKS:
.Project Quality Support in the CSV Equipment Legacy Review
/CSV Equipment Remediation Projects
.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
.Planning, coordination, execution and reporting of activities related to the project
REQUIREMENTS:
.Higher education (Engineer or similar) and background in IT
.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
.English fluent, German Fluent
Others:
Location: Canton Basel-Country or Solothurn
Hourly rate: negotiable
Start date: ASAP
End date: 19.12.2014 (extension possible)
Feel free to ask me for further information!
Frank Arnold
Recruitment ConsultantMichael Bailey International is acting as an Employment Business in relation to this vacancy.
OVERALL RESPONSIBILITIES & TASKS:
.Project Quality Support in the CSV Equipment Legacy Review
/CSV Equipment Remediation Projects
.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
.Planning, coordination, execution and reporting of activities related to the project
REQUIREMENTS:
.Higher education (Engineer or similar) and background in IT
.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
.English fluent, German Fluent
Others:
Location: Canton Basel-Country or Solothurn
Hourly rate: negotiable
Start date: ASAP
End date: 19.12.2014 (extension possible)
Feel free to ask me for further information!
Frank Arnold
Recruitment ConsultantMichael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges