Analytical Project Manager
NTO QUALITY
Stein, Switzerland
vor 19 Tg.

Job Description

Stein is a site of strategic importance for the manufacturing and launch of innovative medicine. One of the most important pharmaceutical production plants of Novartis Technical Operations is located in Stein.

The site Stein Steriles is launch site & center of excellence worldwide for innovative sterile drug products for injection containing Biologics as well as manufacturing site for clinical supplies of sterile dosage forms required in global clinical studies.

The Analytical Project Manager is a member of the Analytical Science & Technology (AS&T) team. Main focus lies on management of projects with respect to drug product launches and / or drug product transfers to the site.

He / she is responsible for management of all administrative activities related to analytical methods and testing including capacity and cost evaluation according to the NVS manufacturing manual.

Furthermore, he / she is the first point of contact for development and third party contacts and acts as an interface to the internal Quality and AS&T department.

The main accountabilities are :

  • First point of contact for development and 3rd parties
  • Acts as interface to internal QA / QC and AS&T department
  • Responsible for the capacity and cost evaluation according Novartis regulations for QC / AS&T activities
  • Subject matter expert in analytical sub-teams representing the commercial manufacturing site
  • Author / Review of internal documentation incl. verification / validation reports, transfer documents
  • Review of dossier modules for first submission
  • Single Point of Contact in Health Authority response teams representing the commercial manufacturing site for analytics
  • Pre-approval inspection and Audit support for drug product launches
  • Handling of analytical deviations and OOx related to launch activities
  • Support for initial establishment of analytical testing procedures
  • Minimum requirements

  • Technical education & 10+ years relevant experiences or University degree & 5+ years working experiences
  • German and English fluently spoken / written
  • Advanced quality and technical understanding
  • Several years’ experience in pharmaceutical analytics / QC
  • Experience in project management highly desirable
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