QC Stability Reviewer
Review analytical release and stability data that has been generated within the department
Critically review raw data and liaise with other departments
Review of data generated for pre-formulation activities
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
Assist Stability Centre Team Leader with management of stability programmes
Formulating weekly work schedules with support from Stability Centre Team Leader
Reviewing analytical documentation and ensuring Right First Time KPIs are achieved
Trending of finished product results
Maintaining laboratory SOPs and specifications in a state of compliance
Key Job Requirements:
At least 3-5 years' experience working within a cGMP environment (HPRA and FDA approved).
- 2 years of bench work and 1 year stability within a QC laboratory
A BSc in a related discipline is a must.
Extensive experience with HPLC, GC is required with a minimum of one years Stability review experience
Ability to advise and lead a small team of analysts.
Ability to trouble shoot, identify analytical issues and follow up with corrective actions.
If you think you meet the criteria for this job contact Clara on 01 4744676 or email email@example.com
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