- 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.
- 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.
- 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