POS 2827
Status 8

Device & Packaging Transfer Team Lead

Beschreibung: For one of our Swiss Pharma clients we are looking for temporary support as: Device & Packaging Transfer Team Lead (M/F/*)
  • Manages Device & Secondary Packaging related to transfer and launch activities
  • Leads project team for transfer and launch project related to device assembly and secondary packaging processes
  • Responsible for adherence of several KPIs
  • Defines and monitors project scope and timing
  • Assures that all activities are performed acc. To current processes and standards (GMP, HSE, Regualtory). Ensures PAI readiness
  • Performes Due Diligence initiatives and deal negotiations for selected in-license and out-license projects
  • Act as a manufacturing representative during device development stages (design control) and the packaging design process
  • Supports site engeneering in defining assembly & packaging equipment design / qualification related to transfer / launch products
  • Start: 01.03.2019 / 6 Months / 5 days per week on-site
  • PhD / Dipl. Ing. In Mechanical Engineering or Pharmaceutical Technology
  • Min. 10 years experience in manufacturing science and technical development / Quality in assembly & secondary packaging projects
  • Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
  • Fundamental understanding of standard device/packaging analytical testing
  • Expert in reviewing and writing technical reports
  • Knowledge regarding design control, documentation, risk management and processes such as DMR, DHF, pFMEA, Design Verification, and URS
  • 21 CFR part 210/211, 21 CFR part 4/820 and ISO 13485 knowledge, ISTA, ASTM, EMA medical device directive
  • Travel Willingness (short and long distance as well as time periods)
  • Business fluency in English
Bemerkungen: WANTED: Device & Packaging Transfer Team Lead (M/F/*). Please contact +49 89 18 90 998 30 or Skills: Design Control / Validation / Assurance / Review, English, Medical Devices, Packaging

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