We are looking for a QC Analyst to join the Stability department with an internationally recognised pharmaceutical client based in Dublin.
The activities of this role relate to the review and approval of all raw data generated during routine and development release & stability testing process.
If you are interested in this job apply below.
I also have more senior or indeed junior roles within Engineering, QC, QA, QP, Validation, CQV, PM and other areas of pharmaceutical, medical device, and biologics companies.
Send me an email or simply your CV to schedule a confidential chat (014744692) - to andrius "at" sigmar.ie
• 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.
• Critically review raw data and liaise with the Analytical Development Team, Stability Centre Team, Technical Affairs and Quality Assuranmce on any out of trend data.
• 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 results and liaisie with client on any non-conformances.
• Compile formal stability reports including Time-Point and End of Study reports.
• Assist Stability Centre Team Leader with the 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 1-2 years of QC work and 1-year stability department based experience within a cGMP environment (HPRA and FDA approved).
- 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 troubleshoot, identify analytical issues and follow up with corrective actions.
- The ability to work well with all key contacts both internal and external to the organization.
Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.