Experience

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  Health Products Regulatory Authority (HPRA)

  • Dublin, County Dublin, Ireland

  • GMP Inspector

    • Jan 2023 - Present
    • Dublin, County Dublin, Ireland

• 

  The Compliance Group

  • Ireland

  • Senior Regulatory Consultant

    • Oct 2022 - Jan 2023
    • Ireland

• 

  HPRA

  • Dublin, Leinster, Ireland

  • Inspector

    • Jun 2016 - Oct 2022
    • Dublin, Leinster, Ireland

    GMP inspector with the Health Products Regulatory Authority.

• 

  LEO Pharma A/S

  • Manufacturing Development Executive

    • Jul 2015 - Jun 2016

    - Designed and performed lab scale investigations. - Collaborated and assisted in RCA investigations.- Led projects designed improve production processes. - MSAT representative on Production Support Group (PSG).

• 

  Gilead Sciences

  • Ireland

  • Quality Assurance Specialist

    • Feb 2014 - Jul 2015
    • Ireland

    - Reviewed batch documentation.- Assisted in deviation investigations.- Backroom, regulatory audit experience.- Assisted in customer complaint investigations.- Responsible for CMO batch documentation review.- Reviewed clinical trial IMP regulatory documentation.

• 

  University College Cork, Ireland (UCC)

  • Ireland
  • Higher Education
  • 700 & Above Employee

  • Clinical Trial Pharmacist

    • Oct 2012 - Feb 2014

    -TRUST Clinical Trial-Acted as trial pharmacist.-Assisted in trial design and setup at Ireland site.-S.O.P writing and implementation.-Study drug storage management.-Developed and managed the pharmacy file.

  • Researcher

    • Oct 2011 - Feb 2014

    - Conducted research into competency development and medicine safety.- Presented work-shops and lectured in clinical pharmacy and prescribing safety.- Peer reviewed journal articles.- Assisted in the building of an electronic adverse event reporting system.

• 

  RCSI

  • Cork

  • Masters of Pharmacy Student

    • Sep 2010 - Dec 2011
    • Cork

    Project Title: ‘The implementation of a quality manual to align with ICHQ10 guidelines.’

• 

  Pfizer

  • Lough Beg Drug Product Plant, Co.Cork

  • Quality Assurance/Pharmacy Intern

    • Mar 2011 - Aug 2011
    • Lough Beg Drug Product Plant, Co.Cork

    -Worked as part of Quality Assurance team.-Reviewed batch records and investigated batch deviations.-Project: ‘Creation and Implementation of a Quality Manual’.-Studied ICH Q10 and ICH Q7a guidelines in detail.