Stability Specialist

01.07. | Temporary | 100%

Stability Specialist

Stability Specialist
CDI, 100%

The position

The Stability Specialist is responsible for handling the stability program for all commercial products
internally and externally. Performing tracking and trending stability data results. Key Subject Matter
Expert in commercial drug product and drug substances stability.

Your tasks / duties

Commercial Stability program:

  • Handle commercial stability program for commercial products: scheduling,
  • batch selection, setup, sampling, coordination, etc."¦.
  • Create stability protocol as well as Master Data management and the creation of stability study (e.g.LIMS system)
  • Track and trend stability data for commercial products internally and externally
  • Participate in external and internal audits
  • Monitor global stability SOP / WP


Reporting:

  • Write annual stability report
  • Manage master data for stability samples
  • Support the management of global reference standards and control products


Support Commercial drug substances and drug product:

  • Collaborate with QA on deviations
  • Lead work activities involving Change Controls and CAPA's
  • Represent department in cross functional projects


Your Profile

  • Scientific university degree, Master or Bachelor
  • At least 5 years of experience in pharmaceutical industry
  • Previous experience in stability management
  • Strong Knowledge of GDP/GMP regulations
  • Fluent in English and French, both written and spoken


Your contact at Kelly Scientific
Sophie Darthenay
Engineer in Biology
Consultant Professional Staffing Life Science

01.07.2020
Employee, 100%

Contact

Kelly Services Switzerland

Sophie Darthenay


Kelly Life Sciences

rue du Rhône 114Geneve

Industry

Human resources / Personnel services

Kelly Life Sciences

rue du Rhône 114Geneve

Industry

Human resources / Personnel services
Salary

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