CSV Qualification and Validation Engineer

Switzerland  ‐ Onsite
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Description

CSV, Computer System Validation - Specialist

Start date: asap

Industry: Medical Device

Assignment type: temporary

Location: Switzerland (German Part)

Our client is one of the most significant Medical Device Company based in Switzerland.

They are now seeking a passionate CSV (Computer System Validation) specialist who brings in the expertise to contribute to a professional and motivated environment.

Specialized in new products, processes and technologies, our client is not only known for its innovative and adaptable corporate entertainment, but is also a very desirable employer with more than 1000 motivated employees in the subsidiary.

You're Responsibilities:
  • Verification & Validation of a medical device system - development and execution
  • Overviewing GxP-Compliance in the project for various retrospective validations.
  • You create the Validation documentation for GxP relevant system elements.
  • Implement QA / QC for all tests in relation to the project
  • Planning, coordination, execution and reporting of activities related to the project


- User requirement specification

- Compliance Plan

- Risk Assessment

- Test Plan

- Technical Specification

- Hardware Qualification Table

- User acceptance Test Script

- Test Report

- Compliance Report

You're Profile:
  • 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
Start date
10/2015
From
Real Staffing
Published at
02.10.2015
Project ID:
993367
Contract type
Freelance
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