Verification Engineer - Device Development (m/f)

REFERENZNUMMER:

355547/11

IHRE AUFGABEN:

-Translate cGxP and normative requirements (e.g. USP, Ph. Eur., ISO, ASTM) into practical lab processes (e.g. test sample management, test method validation and transfer, discrepancy management and OOS, training, change management, complaints), including practical development, implementation, documentation
-Author of protocols, rationales and reports
-Transfer of methods into clinical and commercial facilities/packaging centres
-Lead and track change control activities for test methods and lab processes, assess impact of changes (internal or external) on test method validation and compliance of existing lab processes
-Write, review, approve design verification plans, protocols and reports, support development of rationales
-Justifying chosen approaches (e.g. acceptance criteria, statistical sampling, time points)
-Analyze test data (design capability, trending, k-value)
-Management of unexpected events (e.g. discrepancies, complaints)

IHRE QUALIFIKATIONEN:

-Technical/Engineering degree
-Experience in working in pharma or medical device industry (cGxP, QSR) and with characterization of medical device/combination products, special/innovative packaging, or compact, complex, multi-material hand-held products
-Knowledge of legislation, regulation, industry standards and guidance of medical device/combination products
-Root cause analysis, risk assessment techniques, method or process validation and transfers
-Software for change/discrepancy management (e.g. TrackWise, Condor)
-Excellent command of spoken/written German and English

WEITERE QUALIFIKATIONEN:

Auditor