Description
We are looking for a
Computer System Validation Expert / Medical Devices (m/f)
Reference: -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