Padraig O' Shaughnessy

Experience

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  Pfizer

  Sept 2005 - Jul 2008

  Quality Chemist
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  Merck

  Aug 2008 - May 2009

  Quality Analyst
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  Lancaster Laboratories

  Jun 2009 - Mar 2012

  Senior Analyst
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  Gilead Sciences

  Apr 2012 - Jun 2014

  Quality Chemist

  • Responsible for cross departmental OOS investigations and implementation of corrective actions at all stages of product manufacture i.e. warehouse, production, packaging, QC and QA. • Proficient in HPLC, GC, IR, DSC and KF analysis of Solid Oral Dose products and API’s.• Create and submit change controls prior to carrying out changes within the laboratory.• Excellent writing skills developed by writing SOP's, protocols and investigation reports.• Training Administrator (Lead) for QC Department. Carry out training with new starters on SOD testing.• Assist in troubleshooting equipment and collect information to resolve future issues. Show less

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  Mylan

  Jun 2014 - Jun 2018

  • Lead project to implement a QC testing lab from start-up to go-live phase within challenging timelines. • Generate project plans outlining strategy for implementation of computerised systems and lead projects within QC.• Lead a team of analysts with key priorities including Computer System Validation, introduction of new instrumentation and maintenance of LIMS/CDS systems.• Manage and support team members with technical queries, prioritisation of workload and career development. • Support in both internal and external audit preparations including regulatory inspections. Show less • Lead project to Implement LIMS/CDS into the QC Department.• Involved in the development of training material and testing of masterdata as part of the cross departmental project to implement SAP.• Administrator for LIMS/CDS system.• Training Administrator (Lead) for QC Department, which includes creating training packages for new starters and ensuring that the group meets site performance metrics.• Support in audit preparations within the QC Department.• Perform Frontline Regulatory Audit interaction as part of Regulatory Inspections. Show less

  • QC Specialist

    Apr 2016 - Jun 2018

  • Senior QC Analyst

    Jun 2014 - Apr 2016
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  Viatris

  Jun 2018 - now

  Senior Laboratory Informatics Engineer

  • Lead projects from outset to close to upgrade Global Laboratory LIMS/CDS systems and multi-lab rollout of upgraded systems.• Develop and maintain project plans, including timelines and cost estimates, and present to Senior Management. • Identify and engage with key business and technical stakeholders, lead gap assessment, business requirements mapping and scope definition workshops at project outset. • Lead regular project communication meetings to keep key stakeholders informed of progress updates, issues and risks. • Lead daily project scrum calls with project team, ensuring daily activities focus on the project scope.• Provide technical support to ensure best processes are adopted by sites.• Develop and validate customised analyses utilising LIMS/CDS interface.• Experience leading projects virtually across numerous Global sites within challenging timelines.• Collaborating with project team to troubleshoot and overcome issues with complex technical solutions across a wide range of pharmaceutical workflows Show less

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  Accenture

  Jun 2021 - now

  Manager Management Consulting