ID EXISTS
POS 2827
Status 8
DJM 1

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/*)
Tasks:
  • 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
Qualifications: 
  • 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 maria.haushofer@k-recruiting.com Skills: Design Control / Validation / Assurance / Review, English, Medical Devices, Packaging

Bei uns sind Sie richtig. Nicht nur dank perfekt passender Projekte.

UNSERE LEISTUNGEN

Was Sie als Consultant von uns erwarten können.

IHRE VORTEILE

Weshalb sich eine Zusammenarbeit mit uns für Sie lohnt.

47