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Stability Analyst

Job description

Job Purpose: Reporting to the Stability Centre Team Leader, the primary purpose of the Stability Analyst is to review and approve all raw data generated during routine & development release and stability testing.

 

What does this job involve?

  • The Stability Analyst will review analytical release and stability raw data that has been generated within the department for both commercial and non-commercial products in a timely manner and in accordance with cGMP.
  • Critically review raw data and liaise with the Analytical Development Team Leader, Stability Centre Team Leader, Technical Affairs and QA on any out of trend data.
  • You will review of data generated for pre-formulation activities, for example; Photostability - forced degradation studies, excipients and active compatibilities for both drug product and API.
  • Perform laboratory investigations to resolve non-conforming data or out of trend data and liaising with clients on any non-conformances.
  • Compile formal stability reports including Time-Point and End of Study reports.
  • The Stability Analyst will assist Stability Centre Team Leader with management of stability programmes, i.e. calendar management, stability pulls and placements.
  • Formulating weekly work schedules with support from Stability Centre Team Leader and ensuring that these schedules are communicated and followed.
  • Reviewing analytical documentation and ensuring Right First Time KPIs are achieved.
  • Maintaining laboratory SOPs and specifications in a state of compliance.

 

What should you have?

  • At least 2 years of bench work and 1-year stability within a cGMP environment (HPRA and FDA approved).
  • Ability to critically review analytical data. Possessing excellent attention to detail is a must.
  • Experience troubleshooting analytical issues and following up with corrective actions.
  • The ability to work well with all key contacts both internal and external to the organisation.

 

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