Computer System Validation Specialist (m/f)

REFERENZNUMMER:

235680/3

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist