Commercialization Packaging & Device expert (NOVJP00024742) (m/f)

Job type:
on-site
Start:
02/18
Duration:
6 MM++
From:
Hays AG
Place:
Basel-City
Date:
12/15/2017
Country:
flag_no Switzerland
project ID:
1470994

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We are looking for a
Commercialization Packaging & Device expert (NOVJP00024742) (m/f)

Reference: en
Start: 02/18
Duration: 6 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen

Your tasks:
  • Provide technical expertise from commercial point of view during device development stages and process commercialization
  • Support Launch Site Decisions at e.g. PAC (Post Approval Commitment) by providing analysis of technology, capacity, skills by performing interfunctional evaluations
  • Manage technical launch activities (process, technology, capacity, resources) for assembly and packaging at involved sites
  • Assure that all activities are performed according to current processes and standards (GMP, HSE, Regualtory)
  • Ensure PAI (Pre-Approval Inspection) readiness
  • Act as a manufacturing representative during device development stages (design control)
  • Act as a manufacturing representative in the packaging design process for the BTDM product portfolio


Your qualifications
  • Education (minimum/desirable): PhD, Dipl. Ing. in Mechanical Engineering or Pharmaceutical Technology
  • Fluent in English and local language (German) an advantage
  • Extensive experience in Pharmaceutical Manufacturing (preferably assembly & packaging) / Manufacturing Science and Technology / technical Development in assembly & secondary packaging projects
  • Thorough understanding of product processes and strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
  • Knowledge in design control, documentation, risk management and processes such as DMR (Device Master Record), DHF (Design History File), pFMEA, Design Verification, and URS (User Requirement Specifications)



Skills:
- Project manager