Brid Murphy Email & Phone Number

Ireland

Dublin, Ireland

Pm3 Filling And Inspection Dun Laoghaire

Accountable for the development, review and update of Standard Operating Standards, protocols and reports. Work closely with Subject Matter Experts to ensure accurate and complete documentsRaise and manage Change Controls, deviations and CAPAs to ensure timely closureAbility to work as guided by objectives and milestones of the department or assignmentsStrong attention to detail, including the ability to proofread documents Ability to help others understand and implement complex instructionsA site point of contact for documentation/EDMQ issuesLiaised with System Owner and Operations teams regarding documentation changesWorking knowledge of Pharmaceutical, Biotech industries and aseptic processing

Incoming Quality:Lead a group of Inspectors in their day to day dutiesScheduled sampling and inspection of raw materials and components to ensure lead times were metReviewed and approved components for use in ManufacturingRaised, investigated and managed NC and CAPAsEnsured all activities in QCI were performed as per procedure and GMP requirementsSupervised all required duties within the QCI Department, which included:Maintenance and control of defect sets, sample shipments, Action Advices, review of defect classifications, generation of defect sets, labelling and distribution of QC samples, Raised customer complaintsPrepared, reviewed and approved Plant Supports, Protocols and SOPsLiaised with QA and other departments to ensure all activities and investigations were carried out and completed to GMP requirementsPrepared Annual Product ReviewsResponsible for contributing to and assisting with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits Co-ordinated internal and external calibrations and reviewed associated documentationCo-ordinated external testingManaged retain program

Led a group of Analysts in their day-to-day duties including testing of raw materials, in-process, intermediate, finished product, stability and water samplesScheduled Laboratory testing to meet company requirements, lead times and technical transfer activitiesEnsured testing was performed in compliance with site SOPs and PharmacopoeiasReviewed and approved documentation Approved batches on both LIMS and MAPS systemsRaised and performed lab investigationsReviewed and generated water reportsMaintained both internal and external calibration lists, liaised with vendorsPrepared and maintained product Trend ReportsPrepared and reviewed SOP’sPrepared Laboratory Investigations and Deviation reportsReviewed Method and Equipment Validation Scheduled and performed Training of Laboratory analystsAssisted in Regulatory/ Corporate Audits

Master'S Degree, Pharmaceutical Quality Assurance & Regulation

Bachelor Of Applied Science (B.A.Sc.), Chemistry & Maths