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QC Stability Specialist

Job description

QC Stability Reviewer

 

Job Responsibilities:

  • 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 chenry@sigmar.ie

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