Beschreibung
* 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.)
* 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
Schlagwörter:
FDA, Gamp, GMP, Validierung, ISO
Kontaktperson: Vertriebsassistentin Frau Anna Krause
FERCHAU Engineering GmbH
Niederlassung Rosenheim
Mangfallstr. 37
83026 Rosenheim