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Compliance Specialist

Quality & Laboratory
Cork
Katie Reidy
Temporary
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Job Reference: JO-2005-65195_1589984909

Summary:


Responsibilities


· Leads GEMBA walkdowns frequently, ensuring that areas are always audit ready. Assist them in formulating corrective plans, putting a process in place, confirming that actions are addressed.


·Supports the Vaccine IPT compliance plan and generation of quality metrics


·Complete review and approval of IPT documentation


·Tracking and directing follow-up activities, to correct any non-conformity


· Leads GEMBA walk downs


·Participate in the preparation and hosting of regulatory and customer audits


·GMP training delivery to IPT personnel


·Investigation of Minor Deviations


·Provide Compliance guidance to Operating procedures


·Review Deviation Trends and identify effective CAPA's, where necessary


·Member of the site Permanent Inspection Readiness (PIR) team, ensuring that the Vaccine IPT department is Permanently Inspection Ready


·Proactive monitoring of CAPAs, to ensure holistic trends are proactively resolved


· Participates in the overall CAPA effectiveness programme and continued improvement on root cause analysis and follow-up CAPA


·Participates in Quality Risk Management


·Optimises existing operations and practices with a focus on continuous improvement initiatives


Qualifications/ Experience:


·3rd Level Degree in Science/Engineering


·5 years' experience in Biopharmaceutical or Pharmaceutical industry


·>2 years' experience in a Quality / Operations role


·Knowledge of and experience in applying Lean Six Sigma and Lean methodologies (e.g. 6S)


·Relevant GMP standards


·Demonstrated technical knowledge and experience in compliance (GMP, Engineering, Technical)


·Desirable: Evidence of Continuous Professional Development



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Katie Reidy
Katie Reidy
Talent Consultant
Quality & Laboratory
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