Caroline Flavin Email & Phone Number

Ireland

Dublin, Ireland

Support the execution of the internal Quality Management System (QMS) to ensure compliance to all relevant standards within the company, including, but not limited to Product Complaints, Deviation & CAPA, Out-of-Specification Investigations, Change Control, Product release for distribution, Internal Audit, SOPs and Controlled Documents, Training, Artwork approval, Validation and qualification.Design, Implementation and validation of eQMS (Reliance EtQ) for Jazz, continued enhancement of system to ensure meeting Jazz's global requirements

Dublin 4

• Batch file review• Management of the Quality Systems • Updating, review and approval of forms and SOPs• Generating weekly and monthly reports on the Quality Systems• Log and review stability reports• Log and generate forms detailing contractor deviations• Log and generate forms detailing contractor change controls• Generator internal change controls and deviations• Review and approval of Artwork• Ongoing preparation for IMB audit

County Dublin, Ireland

My primary duties in this role include:*Reviewing batch files both paper and electronic to a high standard.*Review and disposition of intermitted batches on EBR*Assisting processing supervisors and operators in resolving issues.*Contact point for quality and EBR related queries from operations and quality.*Training analysts on review of efexor batch files both paper and electronic.*Reviewing QAR's related to EBR for quality specialists to ensure that they are correct and all actions on EBR have been carried out.*Coordinationg the end to end list to ensure that batch files are prioritized to meet shipping schedules.*Reviewing reject batch files and ensuring that they ae QP dispositioned with in 60 days of closer of QAR.*Maintaining the archiving system.*Participation in cGMP audits.Project work I have been involved in:*Part of the Electronic Batch Record implementation team, which helped design and review the design spec, working instructions, OQ and PQ for all 5 stages of the efexor process.*Part of a cross function team which was awarded a PGM innovation award for "Efexor: the next Decade." *Helped design and implement new documentation checklist to facilitate review by exception in the Efexor QA department.*Helped design and implement new EBR intermitted documentation checklist to facilitate approval of these batches by the QA analyst.

My duties in this role included:* Reviewing batch files to a high standard for QP release.* Coordination the blend pool to ensure that the batch files are reviewed so that processing are never waiting on batches for the encapsulators.* Training new analyst on review of efexor batch files* Assisting processing supervisor and operators in resolving issues.* Holding the efexor morning meeting when required.* Working with processing to reduce the number of pages and entries in there paper to improves right first time.* Reviewing reject batch files and getting them to the QP in a timely manner.* maintaining the archiving system.