Embark on a challenging opportunity as a Senior Quality Control Professional in our Dublin office. As part of this exciting role, you will be responsible for conducting analytical testing of raw materials and validation under minimal supervision.
1. Develop and execute analyses with high efficiency and precision.
2. Plan and perform complex routine/non-routine methods and procedures across various assays.
3. Evaluate, backup/archive, trend, and approve analytical data accurately.
4. Analyze and troubleshoot problems, communicating effectively with stakeholders.
5. Initiate changes to controlled documents as needed.
6. Participate in audits, initiatives, and projects spanning departmental or organizational scope.
7. Review protocols, validate assays, and perform equipment qualification/verification tasks when required.
8. Introduce new techniques to the lab, including method transfers, reports, validations, and protocols.
9. Contribute to regulatory filings as necessary.
10. Investigate lab issues when required.
11. Evaluate lab practices continuously for compliance.
12. Approve lab results accurately.
13. Maintain liaison with external resources.
14. Coordinate LIMS data for commercial and import testing onsite (where applicable).
15. Represent the organization on cross-functional teams.
16. Train colleagues as needed.
Requirements:
* A Bachelor's degree in a science-related field is essential.
* Minimum 4 years of experience in biopharmaceutical quality control or related GMP laboratory experience within the pharmaceutical or medical device industry.
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products is necessary.