Validation Expert (m/f)

Michael Page

Sede:
Settore: Chimica / Farmaceutica / Healthcare
Funzione: Ingegneria / Produzione / Professioni tecniche
Data pubblicazione: 12 Febbraio 2019

Profilo

Our client is a medical device company focusing on the development of treatment solutions for liver diseases and heart failures.
  • Management of all tasks with respect to the verification and validation activities (e.g. validation of software, processes, products, equipment etc.) as well as all associated revalidation activities
  • Responsible to generate, review, edit and approve qualification and validation / revalidation protocols, process specifications, FMEAs, test plans and summary reports as well as other associated documents to allow conformance to regulations and standards
  • Responsible to generate, review, edit and approve, SOPs, CAPAs, and other applicable documentation as part of the identified tasks during the verification and validation activities
  • Responsible to analyze testing results using statistical techniques and determining acceptability
  • Responsible to investigate and troubleshoot problems identified during and associated to verification and validation activities and to determine solutions or recommendations for changes and/or improvements
  • Responsible for the validation of software used within the quality management system (e.g. software controlled test equipment used during in-process inspection)
  • Support the change control proves of SOPs and other applicable documents
  • Support the preparation and update of the respective KPIs and management reports
  • Lead cross-functional teams to plan and facilitate Qualification/Validation activities within the organization
  • Responsible to cover the QA area while vacation

  • Technical Bachelor`s Degree in a related field, Master's Degree an advantage
  • At least four years of experience within the field of medical device verification and validation
  • Experience in Quality Assurance activities/techniques
  • Strong technical expertise when reviewing and approving validation protocols, process specifications, FMEAs, test plans and summary reports and other verification and validation related documents
  • Experience in FDA/ GMP/ QSR /ISO13485 and within statistical techniques
  • Proven leadership qualities, including making decisions to meet the goals set and leading effective meetings
  • Ability to develop a "hands-on" approach, requiring personal initiative, reliability and responsibility while operating at a high level of performance and efficiency maintaining confidentiality and meeting deadlines
  • Strong written and verbal communication skills, including report writing
  • Fluency in English is required, additional languages (e.g. German) would be beneficial
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Michael Page
http://www.michaelpage.it

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