QA Specialist

Pe Global

Kildare

PE Global is currently recruiting for QA Specialist for one of our clients in Kildare. Please call Catherine on 0214297900 for more information. Responsibilities of the role: QA support for qualification activities - review and approve equipment/utility qualification documentation from design to post execution. Review / approval of technology documentation. Review/approval of production instructional documentation (SOPs and batch records) to ensure they are up to date, compliant, and support efficient production. Participate in the internal audit programme as required. Maintain tracking system for project document review status. Review event/investigation reporting including support of Manufacturing Operation teams with investigations and resolution of discrepancies. Co-ordinate and review change controls as required. Perform completion of batch disposition packs within required timelines /Work with site QPs to ensure timely issue resolution to final disposition. Review of regulatory documentation. Assist in the creation and maintenance of up to date QA policies, SOP’s and reports. Assist in the development of training curricula and records for the QA Operations Group. Assist in the creation and maintenance of up to date QA policies, SOP’s and reports. Education/Experience: B.Sc. degree in biology, chemistry or equivalent. At least 2 years experience in a QA role in a pharmaceutical manufacturing environment is required. Experience with batch records and investigations is essential. Experience is solid oral dose would be an advantage. If you are interested in this position, please forward your CV to catherine.osullivan@peglobal.net or call 0214297900. This job originally appeared on RecruitIreland.com.

2227 days ago