Computer System Validation Specialist (m/f)

Job type:
on-site
Start:
asap
Duration:
12 MM++
From:
Hays AG
Place:
Southern Germany or Austria
Date:
03/11/2014
Country:
flag_no Austria
project ID:
677464

Warning
This project is archived and not active any more.
You will find vacant projects in our project database.

We are looking for a
Computer System Validation Specialist (m/f)

Reference: 235680/3-en
Start: asap
Duration: 12 MM++
Place: in Southern Germany or Austria
Branch: Medizintechnik

Your tasks:
  • GxP computer system validation (CSV)
  • Support the SDLC Software Development Life Cycle (Detailed Design, UAT Script Testing, security deliverables, BIA and disaster recovery)
  • Risk Management (ISO 14971)
  • Approving specific computer system validation documentation
  • Planning and implementation of qualification/validation activities
  • Ensure compliance through assisting in audits


Your qualifications
  • Experienced with validation processes and responsibilities
  • Knowledge of 21 CFR 820, 21CFR820.100 Part 11, FDA QSR, ISO 13485, ISO 14971, ISO 60601 , ISO 62304 and GAMP5
  • Working experience with validation computer systems for use in a FDA-regulated environment
  • Engineer Degree or similar with IT Background
  • Profound experience in Computer System validation (CSV) and SDLC (systems development life cycle)
  • Profound experience within Medical Devices Industry
  • Profound experience in Quality Management Systems
  • Solid experience with Project Management Tools such as MS Project
  • Fluent in English and German



Skills:
- Qualification/validation specialist