Senior Associate Quality Control NPI
RK2498
12 Months
Dublin
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.
Duties:
1. With a high degree of technical flexibility, work across diverse areas within QC
2. Plan and perform analyses with great efficiency and accuracy.
3. Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
4. Report, evaluate, back-up/archive, trend and approve analytical data.
5. Troubleshoot, solve problems and communicate with stakeholders.
6. Initiate and/or implement changes in controlled documents.
7. May train others as necessary
8. Participate in audits, initiatives and projects that may be departmental or organizational in scope.
9. Write protocols and perform assay validation and equipment qualification/ verification.
10. Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
11. May contribute to regulatory filings.
12. May conduct lab investigations as necessary.
13. Evaluate lab practices for compliance on a continuous basis.
14. Approve lab results
15. May represent the department/organization on various teams
16. May interact with outside resources.
17. Create APPX data files and randomisation memo to facilitate data analysis.
18. LIMS data coordination of commercial and import testing on site where applicable
19. May provide technical guidance. May contribute to regulatory filings.
20. May represent the department/organization on various teams. May train others.
21. May interact with outside resources
Education and Experience :
22. Bachelor's degree in a Science related field is required.
23. 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,
24. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or rachel.kent@lifescience.ie for further information.