We're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Ideally the person will be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance. This role is for an experienced and technically strong associate who will spend 90% of their work day performing testing. The successful candidate would contribute to team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within team. This role will support manufacturing operations, as such some extended hours, shift and weekend work may be necessary as required.
Responsible for:
1. Endotoxin testing of water, in-process and drug product release samples
2. Bioburden testing of water & in-process drug product samples
3. Sterility testing
4. Water sampling
5. Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.
6. Writing technical reports
7. Media fill reconciliation and inspection
8. Weekend bioburden cover
9. Perform analytical testing as a main priority with efficiency and accuracy
10. With a high degree of technical flexibility, work across diverse areas within the lab
11. Plan and perform multiple routine/ non-routine methods and procedures with a large variety of assays.
12. Report, evaluate, archive, trend and approve analytical data.
13. Troubleshoot, solve problems and communicate with stakeholders.
14. Initiate and/or implement changes in controlled documents.
15. Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
16. Write protocols and perform assay validation.
17. Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
18. Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
19. Review and Approve lab results
20. May participate in lab investigations.
21. May provide technical guidance.
22. May train others.
23. May contribute to regulatory filings.
24. May represent the department/organization on various teams
25. May interact with outside resources
Education and Skills:
26. Bachelors degree in a science discipline
27. Biopharmaceutical QC experience in a microbiology lab
28. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
If interested in this posting please feel free to contact Avishek Singh at or 0872827991 for further information.