Paddy Breen

Senior Disposition Specialist at MSD Ireland
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Location
Ireland, IE

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Experience

    • Ireland
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Senior Disposition Specialist
      • Jul 2022 - Present

      Part of the disposition group within MSD Part of the disposition group within MSD

    • Software Development
    • QA Specialist
      • Apr 2019 - Jul 2022
    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Senior QA Associate
      • Apr 2017 - Apr 2019

      • Clinical and Commercial batch record release on PASX (electronic batch record) • QA purposeful presence on the floor • Primary decision maker for on the floor issues that occur out of hours (Shift work pattern) • Quality Point of contact for the triage/nonconformance process on the floor • EDMQ document support (Author, Owner and QA approval on all electronic documentation related tasks incl. protocol’s, standard operating procedures (SOP’s), GMP form’s, technical assessments, reports etc.) • Daily support for quality tasks incl. batch AQL’s, customer complaints, defect certification etc. • PQA certified trainer for Vial and Syringe batch record review training and PQA document owner for multiple SOP’s in relation to QA specific tasks • Active in newly established exception reduction governance team responsible for targeting an automated batch release process in the near future • PQA lead for MES projects concerning the introduction of new ADL products, both commercial and clinical • Team lead for the introduction of lean practices in relation to the process of the release of batch records to the QP • Daily collaboration with cross functional teams to assist in resolving any issues that affect batch review turnaround time • PQA point of contact for the introduction of the first clinical product in ADL with respect to QA support for manufacturing batch records, change controls, SOP’s and the deviation process Show less

    • United States
    • Financial Services
    • 700 & Above Employee
    • Derivatives Specialist
      • Sep 2016 - Apr 2017

      • Highly proficient in MS Excel reporting • Communication with team members to assign tasks to meet client deadlines • Pull pricing data from multiple vendors to assign to a final client specific daily report • Highly proficient in MS Excel reporting • Communication with team members to assign tasks to meet client deadlines • Pull pricing data from multiple vendors to assign to a final client specific daily report

    • Ireland
    • Higher Education
    • 100 - 200 Employee
    • MSc Biotechnology and Business Student
      • Sep 2015 - Jul 2016
    • Events Services
    • 1 - 100 Employee
      • Nov 2014 - Aug 2015

      • Completing tasks to support the manufacture of high quality biopharmaceutical products in accordance with cGMP. Responsible for completing daily cGMP operations according to SOPs and batch record instruction in a cGMP environment.• Independently prioritizing and scheduling activities to support business needs and to meet requirements of the master production schedule. Assist in the development of Standard Work Plans (SWP) for the area, and reporting deviations from the SWP• Providing training and support to new staff members of the Process Team to ensure that manufacturing targets are met Show less

      • Jun 2014 - Nov 2014

      • Good Manufacturing Practice (GMP) experience• Trained in visual inspection operations as outlined by the Standard Operating Procedure (SOP)• Daily practice in writing Product Batch Records with accuracy and precision• Tasks were carried out in a timely fashion to adhere to cold chain demands and to get the product out to the market as quickly as possible• Experience in aseptic techniques for syringe control

    • India
    • 1 - 100 Employee
    • Retail operative
      • Oct 2011 - Dec 2012

      • Customer satisfaction • Follow strict guidelines • Customer satisfaction • Follow strict guidelines

    • Official programme seller
      • Jan 2006 - Sep 2010

Education

  • Institute of Technology, Sligo
    Master's degree, Industrial Pharmaceutical Science (QP)
    2020 - 2022
  • University College Dublin
    Master's degree, MSc Biotechnology and Business Student at UCD Michael Smurfit Graduate School of Business
    2015 - 2016
  • University College Dublin
    Bachelor of Science (B.Sc.), Microbiology, General
    2010 - 2014

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