Responsible for leading process and equipment investigations, authoring complex process deviations, Quality Notifications, driving continuous improvement initiatives, CAPA close out, IPT Standard Operating Procedures and Standard Work Instructions and change controls. Ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers.
• Investigate and author complex process deviations. Identify robust Corrective Actions and manage actions through to completion.
• Lead multifunctional teams to complete improvement projects for IPT and actively participate, and lead, on-site Kaizen activities and investigations on behalf of IPT (e.g. Kaizen and investigation activities on processes and systems.)
• Collaborate with IPT colleagues and non IPT colleagues, particularly Quality, EHS, Technical Engineering, in completion of tasks to ensure best practice outputs e.g. lead and in some cases partner with validation, maintenance and production operators in the investigation of complex equipment performance issues.
• Work with coaches/engineers to apply lean tools to process data in order to complete process improvements e.g. KATA, SMED, standardized work etc.
• Complete review, approval and close out of technical documentation including corrective actions, changes controls, and Technical Engineering protocols as required, in line with site standard approval process.
• Identify, troubleshoot, investigate and remedy process and equipment issues and incidents, using Lean Six Sigma tools as applicable. Lead multifunctional root cause analysis investigations for equipment and process issues and incidents.
• Complete process and equipment FMEA and change controls, ensuring action closeout.
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
• Lead continuous improvement projects through the identification of CAPAs from system failure investigations and investigation reports.
• Execution and development of change control, and lead Kaizen events as appropriate.
• Lead complex multifunctional root cause analysis of system, process and equipment failures, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; oversee and implement subsequent corrective action, through the change management system.
• Complete Customer complaint investigations and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.
• Required to comply with company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Work collaboratively to drive a safe and compliant culture in Carlow.
• May be required to perform other duties as assigned.
• Bachelor’s Degree or Higher preferred; ideally in a Science, Engineering or other Technical discipline.
• 3-5+ years’ experience required.
• SAP knowledge and experience required.
• Proficiency in Microsoft Office and job related computer applications required.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, policy writing skills required.
• Equipment and process validation.
• Sterile filling processes and equipment.
• Lean Six Sigma Methodology experience desired.
• Strategy planning and development.
• Demonstrable analytical and systematic problem solving skills.
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