CSV Specialist

Germany  ‐ Onsite
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Keywords

Description

Our client is a leading Medical Device organisation. They are currently seeking a CSV specialist in the area of automation systms for manufacturing equipment.

Location: Germany
Start: ASAP
Travel 40%
Duration: 13 weeks


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, co-ordination, 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 (not only Pharma)

Language Skills:
• English & German fluent

This is an excellent opportunity to work for a global Medical Device organisation!
Start date
n.a
From
Quanta Consultancy Services
Published at
18.09.2014
Contact person:
Lee Mitchell
Project ID:
777203
Contract type
Freelance
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