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Senior Specialist External Quality Assurance - Fully Remote
Client:
Not specified
Location:
Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
6bfc81c55f87
Job Views:
150
Posted:
21.01.2025
Expiry Date:
07.03.2025
Job Description:
We’re currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Carlow. 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. Evaluate and/or release products with the assurance that the goods were manufactured in conformance to all applicable policies/procedures of the Company and compliance with all governing regulations.
2. Review and approve changes to master batch records or laboratory methods/specifications.
3. Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
4. Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc) both domestic and foreign.
5. Accountable for oversight of an EE involving releasing of products with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.
6. Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight. These components may include review of batch documentation, complaints and deviation investigations.
Education & Experience
1. Experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
2. Minimum four-year degree in Science, Engineering or other relevant technical discipline.
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