Computer System Validation Expert / Medical Devices (m/f)

Job type:
on-site
Start:
asap
Duration:
3 MM++
From:
Hays AG
Place:
Southern Germany
Date:
07/09/2014
Country:
flag_no Germany
project ID:
739349

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This project is archived and not active any more.
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We are looking for a
Computer System Validation Expert / Medical Devices (m/f)

Reference: 244609/3-en
Start: asap
Duration: 3 MM++
Place: in Southern Germany
Branch: Unternehmensberatung

Your tasks:
  • Work with IT Computer System Compliance (CSC) in planning of validations of GXP systems for Medical Devices
  • Requirements Identification and documentation
  • System Test Scripting
  • System Test Execution
  • UAT Test Scripting
  • Writing of Work Instructions/Procedures GXP and ISO 13485


Your qualifications
  • Background in Computer System Validation GXP
  • Knowledge of GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
  • Familiarity with med. device manufacturing plants, SDLC
  • Fluent in English & German



Skills:
- Software developer
- Qualification/validation specialist