Eoin Duff Email & Phone Number

Dublin, Ie

Princeton , Nj, Us

Princeton , Nj, Us

Rahway, New Jersey, Us

Boston, Massachusetts, Us

Boston, Massachusetts, Us

Boston, Massachusetts, Us

Responsibilities and Achievements:•As part of the QA-Integrated Process Team (IPT) key responsibilities involve working directly with production colleagues and being present on the shop floor during critical manufacturing activities to provide direct QA support during component preparation, formulation, filling and inspection.•Key part of site start up activities, developed and executed initial process simulations protocol on vial filling line isolator. Wrote final report and successfully presented to corporate auditors and IMB auditor as part of site’s inspection to receive IMP and MIA licenses. Received zero observations.•Acted as QA scribe providing direct support to production staff on the shop floor during multiple process simulations (Media Fills) and clinical batches on syringe and vial line isolators.•Assisted in building aseptic excellence into manufacturing through process review by working directly with production staff, observing manufacturing processes on the shop floor and performing facilitated reviews for document updates and approvals. •As a site Microbiology SME, performed microbiological risk assessments for change controls and performed audits of manufacturing and support areas •Review and approval of validation protocols and reports •Review and approval of GMP permits•Review and approval of change controls using Trackwise•Review and approval of document updates using online document system MIDAS•Used SAP to track deviations and CAPA, provided QA/SME input into root cause investigations, risk assessments, FMEA’s and process development meetings•Review Electronic Batch Records•Wrote technical memo’s for inclusion in batch packs/protocols•Involved in development of Electronic Batch Records and approvals of associated qualification documents•Developed risk matrix/bracketing approach for site process simulations (media fills) schedule, reduced line time required•Completed Merck Sigma Yellow Belt Project

Responsibilities and Achievements:• QA review and approval of manufacturing documentation including batch records• Preparation of Certificates of Analysis and batch packs for QP review • Review of validation/qualification protocols and reports • Update and review of batch details on inventory management system • Update of Documents using online documentation system PDOCS• Participated in cross functional investigations and impact assessments of microbiological excursions • Developed check list for investigating microbiological environmental OOS results • Review and update Quality agreements• Created and circulated microbiological awareness posters • Assessing Quality events with associated investigation and reports on QTS• Perform weekly walk through audit of manufacturing area including associated audit reports

Rahway, New Jersey, Us

Responsibilities and Achievements:• Ensure compliance with corporate, regulatory and GMP requirements. Assisted in preparation and facilitation of successful IMB and FDA audits.• Assist in the changes to existing documentation of SOP's, as well as the creation of new documents•Review analytical reports and paperwork relating to environmental monitoring, media preparation and sterislisation by autoclave, growth promotion as well as water sampling and analysis including endotoxin testing, in a timely and accurate manner. This includes Microbial limit testing of solid dose, liquid and paste products both sterile and non-sterile, as per USP, EP, JP and harmonized methods. •Preparation of microbiological reports including all test results, environmental and personnel monitoring where appropriate•Assist in the organisation and scheduling of the laboratory workload to ensure the efficient and timely release of raw materials, intermediate and finished products while maintaining project and QC release timelines•Ensure all laboratory personnel are trained in their appropriate duties, and in GMP maintaining all records as appropriate•Supervise, motivate and develop all reporting staff, I completed 3 day management excellence training programme including supervisory skills, motivational skills, learning styles and communication skills.•Ensure that instrumentation in the microbiology laboratory is maintained and calibrated in compliance with GMP requirements•Highlight abnormal trends/deviations to the microbiology manager immediately and complete memo’s, deviation reports and CAPA’s with any associated investigations as appropriate•Highlight and implement continuous improvement opportunities whenever possible•Ensure that the laboratory is adequately equipped and stocked to run efficiently•Represent lab on cross functional teams for technical transfer of products and site wide decommissioning of equipment as well as transition forum for site closure

Rahway, New Jersey, Us

Experience and Achievements:• Achieved promotion to Senior Analyst in less than 12 months• Health and safety representative and fire warden for the Microbiology lab, completed 3 day IBEC Health and Safety Rep training course as well as fire warden training• Prepared loads and ran autoclave for media and equipment • Microbial identification using the Vitek identification system including Gram staining, Catalase test, Coagulase test, Oxidase test, Spore staining• Growth promotion testing of microbiological media• Preparation and freezing of House Isolate organisms• Environmental monitoring: active air sampling, swabs, contact plates, water sampling and analysis, Membrane filtration and endotoxin testing • Sample Log in and reading of results for environmental monitoring programme• Biological Indicator processing with aseptic technique• Maintained 5S initiative within the Lab• Member of the waste management team, involved in improvement initiatives with the on site environmental engineer to classify waste streams and streamline disposal methods

Mainly worked in Tissue Culture Lab responsibilities included:• Set up of spinner flasks and mono-layers with SF9 cells using aseptic technique in biological safety hoods, re-feeding and passaging mono-layer’s and spinner flasks• Carried out Infection of cells with virus stocks as well as manufacture and in process testing of IFA (Immunofluoroescence Assay) slides

Experience and Achievements:Active member of the Haemostasis QC team, responsibilities included:• Carrying out all daily duties according to GMP/GLP while working to key metrics in Health and Safety including near miss/observations and accident reports, Quality compliance, Customer service and Cost. • Training of other team members, both test methods and also computer based learning, acted as the labs “key user” and liaised with the information service department. Completed “Train the trainer” course• Calibration and use of various laboratory instruments • Reporting, investigating and root cause analysis of all out of specification results, raising and recording of non-conformance’s and report writing for MRB meetings• Involved in data analysis, problem solving, justifications for product release, customer complaint investigational testing, validation testing, patient sample testing• Member of Haemostasis and “D-Dimer” cross functional technical teams• Attended and led cross functional meetings promoting inter-laboratory liaison brainstorming, research, effective delegation, prioritization and presentation of information to team members and peers including senior management at S&OP meetings• Involved in planning meetings to ensure smooth flow of product from production through QC to QA batch release within agreed time scales. Updated QC schedule to reflect arrival and agreed departure dates of product from QC labExperience and Achievements:Microbiology Lab:• Due to staff resource difficulties, agreed to work in the Micro Lab part time as well as keeping on CFT and Haemostasis QC responsibilities

Master Of Science (Msc), Industrial Pharmaceutical Science (Qp)

Asq Six Sigma Green Belt

Quality Management And Technology

Industrial Microbiology, Microbiology, Chemistry, Biochemistry