Verification Engineer / Verification Technician in Rotkreuz

veröffentlicht
Kontakt
Nadine Schoenmaker, Zürich IT Professionals
Jobtyp
Temporary
jetzt bewerben

job details

veröffentlicht
Ort
Rotkreuz, Zug
Sektor
IT
Jobtyp
Temporary
Referenznummer
12535
Kontakt
Nadine Schoenmaker, Zürich IT Professionals
Telefon
058 201 56 40
jetzt bewerben

Stellenbeschreibung

Verification Engineer

Are you ready for a new challenge and looking for a workplace where you can grow? For our client, an international pharma company in Basel, we are looking for a Verification Engineer.

Job Accountabilities

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 out of specification (OOS), training, change management, complaints) including practical development, testing, implementation, documentation.

This includes in detail:

  • Author of protocols, rationales and reports
  • Support Change Control activities for Test Methods and Lab Processes
  • Execute and support testing activities on medical devices/combination products within cGxP regulated or non GxP area
  • Support internal/external Quality inspections of Verification Engineering Labs and help define appropriate responses
  • Support the development and completion of robust, risk-based, medical devices/ combination products verification strategies
  • Write & review design verification plans, protocols, reports and rationales for justifying chosen approaches (e.g. acceptance criteria, statistical sampling, time points)
  • Execute test data analysis (e.g. k-value)
  • Support management of unexpected events (e.g., discrepancies, complaints) for medical devices/combination products within cGxP regulated area

Professional Requirements:

  • Technical/Engineering degree education or equivalent experience
  • Process oriented and analytical thinking
  • Experience in characterization of medical device/combination products or packaging is an asset
  • Experience of working in Pharma or Medical Device (cGxP, QSR) or other closely-regulated environment (e.g automotive- or food industry)
  • Sound knowledge of legislation, regulation, industry standards and guidance around the area of combination products and medical devices is an asset
  • Fluent command of spoken/written German and English
  • Good documentation skills

Demonstrable practical knowledge of the following would be an advantage:

  • Experience with “Zwick” Tensile Force Test Machine
  • Root Cause Analysis
  • Risk Assessment techniques
  • Method or Process Validation and Transfers
  • Software for Change/Discrepancy Management (e.g. TrackWise)
  • additional Statistical qualification

Interested? I look forward to your online application.

Please note we can only consider candidates that are eligible to work in Switzerland.  

Human Forward!