Job Description

Quality Auditor Role:
· Completes review of data, information, procedures, facilities, equipment and systems (inc computer systems) to ensure compliance to SOPs, GMPs and applicable regulations.
· 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.
· Creates and maintains assigned SOPs.
· Perform and review complaints and deviation investigations, change controls and CAPA's.

Required Knowledge, Skills, and Abilities

· Hold a relevant degree in the scientific or engineering disciplines or have equivalent working experience · Experience working in a similar position within the pharmaceutical industry with a good working knowledge of cGMP regulations · Excellent communication skills