Specialist Stability H/F

☞ Interiman

View: 188

Update day: 20-03-2024

Location: Boudry Neuchâtel NE

Category: Pharmaceutical / Chemical / Biotech

Industry:

Job type: Temps plein, Durée déterminée

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Job content

INTRODUCTION:
For an important international pharmaceutical company based in canton Neuchâtel, we are looking for a

Specialist Stability, GQ AS&T
Temporary contract 7 months

DESCRIPTION DE LA MISSION:


Duties and Responsibilities :
Commercial Stability program:
  • Responsible for the handling of commercial stability program for Celgene products: scheduling,
  • batch selection, setup, sampling, coordination, etc.….
  • Responsible for the creation of 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
  • Responsible for the global stability SOP / WP

Reporting :
  • Responsible for the annual stability report
  • Manages the master data for stability samples
  • Support the management of global reference standards and control products

Support Commercial drug substances and drug product:
  • Collaborates with QA on deviations
  • Leads work activities involving Change Controls and CAPA’s
  • Represents department in cross functional projects

PROFIL ATTENDU:
  • B.S. Chemistry, Biology, Microbiology or relevant discipline
  • 5 years of relevant work experience required, preferable in a Pharmaceutical environment
  • An equivalent combination of education and experience may substitute

Required Competencies: Knowledge, Skills, and Abilities
  • Advanced understanding of pharmaceutical regulatory requirements and their impact to commercial laboratory operations
  • Advanced knowledge in stability protocol definition
  • Advanced knowledge in tracking and trending stability data using statistical software programs
  • Advanced understanding of global and regulatory requirements associated with stability programs
  • Advanced skills to drive development of technical or scientific initiatives
  • Advance experience with authorship and able to critically review investigations, interpret results,
  • and generate technical conclusions consistent with Quality management principles.
  • Must be able to recognize and group technical/scientific attributes and drive science-baseddecisions in most technical areas within laboratory operations
  • Advanced Ability to oversee external service providers involved in stability studies
  • Advanced written and verbal communication skills
  • Advanced ability to work independently, and/or lead and participate in team projects
  • Advanced knowledge of Microsoft Word, Outlook, and Excel
  • Advanced presentation and delivery skills
  • Advanced knowledge in English and French
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Deadline: 04-05-2024

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