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QC Stability Reviewer - Ireland  

Helsinn (company)


Posted on : 01 May 2017

Project Description

Our company seeks an experienced Stability Reviewer within Quality Control for a 12 month plus period.

Job Purpose: 
  • Reporting to the Stability Center Team Leader, the primary purpose of the Stability Reviewer at our company  is to review and approve all raw data generated during routine & development release and stability testing.
  • The ideal candidate for this role will be a person who has minimum 3-4 years of bench work and is looking to move to a
  • more administrative role within a QC laboratory.
  • The following is a non-exhaustive list of the type of tasks and responsibilities associated with the role:
    • 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 Center Team Leader, Technical Affairs and QA on any out of trend data. 
    • Review of data generated for pre-formulation activities, for example; Photo stability - forced degradation studies, excipients and active compatibility 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.
    • 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.
    • Trending of finished product results.
    • Maintaining laboratory SOPs and specifications in a state of compliance.

The Person
The successful applicant must possess the following knowledge, skills, qualifications, attributes and experiences.
  • At least 3-5 years' experience working within a cGMP environment (HPRA and FDA approved). 
  • A BSc in a related discipline is a must.
  • Extensive experience with HPLC, IC & GC is required (Desired Level: Subject Matter Expert).
  • Looking to move to a more administrative role within a QC laboratory.
  • Ability to critically review analytical data. Possessing excellent attention to detail is a must. 
  • Ability to advise and lead a small team of analysts.
  • Ability to trouble shoot, identify analytical issues and follow up with corrective actions.
  • The ability to work well with all key contacts both internal and external to the organisation.

The Company 
  • Our company has a commercial presence in over 90 countries and has proven expertise in areas such as Oncology Supportive Care, Gastrointestinal, and Pain and Inflammation medicines.
  • Our company develops, manufactures and packages finished dose forms in tablet, granulate, capsule and gel formats. 
  • In addition, the company carries out final packaging of special dosage forms such as sterile forms and soft gel which are produced by its worldwide network of CMOs