Computer System Validation Specialist (m/f)

Southern Germany or Austria  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description


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

Reference: -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, 21CFR 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
Start date
ASAP
Duration
12 MM++
(extension possible)
From
Hays AG
Published at
11.03.2014
Contact person:
Kerstin Sieber
Project ID:
677464
Contract type
Freelance
To apply to this project you must log in.
Register