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Principal Scientist Stability (m/f/d)

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22/03/2024 100% Freelance
Work at Hays AG
Hays AG
Principal Scientist Stability (m/f/d)
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages - completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.

Description

  • Participates on transfer team for new products to internal and external sites (as required), reviews registrational stability studies and conducts gap analysis against Global Manufacturing and Supply requirements, develops stability data where gaps exist
  • Develops and maintains expertise on the overall stability performance of products manufactured in the global supply chain, including maintaining a working knowledge of the attributes that impact the products'performance/stability profile
  • Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change
  • Perform change control impact assessments and document the stability assessment in change controls
  • Review and endorse change controls as an expanded reviewer and Initiate change controls related to stability operations
  • Responsible for the handling of annual commercial stability program for assigned products in coordination with sample management groups
  • Leads work activities involving Change Controls and CAPA's
  • Participate and/or lead OpEx initiatives to streamline and standardize management of stability programs
  • Acts as an advisor and mentor to stability staff
  • Support health authorities inspection internal and external

Profile

  • Relevant work experience required, preferable in a Pharmaceutical environment B.S. Chemistry, Biology, Microbiology or relevant discipline
  • Expert knowledge and understanding of stability ICH Guidelines and associated policies, directives and thorough knowledge of cGMP regulations
  • Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices
  • Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods
  • Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles
  • Excellent written and verbal communication skills
  • Exhibit strong leadership and decision making skills
  • Advanced knowledge in English and French

Job Offer

  • A very renowned company
  • Continuous support during the assignment
  • Good infrastructure
  • You will work in an international environment

Contact

Hays AG

004962117884297


About the company
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