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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