Quality Auditor - Life Science - Contract - Clonmel
Our Partner in Tipperary area develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Clonmel for over 40 years, exports to over 25 countries around the world with primary markets being Europe, USA and Japan.
They require 2 Quality Auditors so support them.
Quality Auditor Responsibilities:
1. Completes audits of data, information, procedures, facilities, equipment and systems (inc computer systems) to ensure compliance to SOPs, GMPs and applicable regulations.
2. Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
3. Support product recalls and stock recoveries as appropriate.
4. Identify compliance gaps and make recommendations for continuous improvement
5. Creates and maintains assigned SOPs.
6. Perform and review complaints and deviation investigations, change controls and CAPA's.
Experience required as a Quality Auditor:
7. 2 - 5 years' experience in the Pharmaceutical industry which includes experience in a Quality function
8. A relevant degree.
Are you a good fit for a Quality Auditor? Get in touch with us today.
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