Projekt Manager für Computerunterstützte Validierung

*Planning and implementation of qualification / validation activities and projects of existing computer systems according to the Software Development Lifecycle
*Support and consulting during projects handling GxP critical computer systems
*Approving specific computer system validation documentation
*Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
*CSV remediation activities to be conducted in cooperation with a QA CSV lead
*Support the IT deliverables for the CSV remediation
*Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.)

VORAUSSETZUNGEN:

*Knowledge in technical skills like Technical Writing is requested
*Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11 Familiarity with med. device manufacturing plants, SDLC

EINSATZBEREICHE:

Sonstiges