Senior Compliance Specialist

  • Cork
  • Permanent
  • JO-1711-62987_1510746508

Summary

Responsibilities

  • The Senior Compliance Specialist helps to mould the culture to one that supports a High Performance Organisation.
  • Supports the Vaccine IPT compliance plan and quality metrics generation
  • Complete review and approval of IPT documentation
  • Leads walk down and support audits
  • Participate in the preparation for and hosting of regulatory and customer audits
  • GMP training delivery to IPT personnel
  • Investigation of Minor Deviations
  • Investigation of EHS Incidents
  • Provide Compliance guidance to Operating procedure
  • Review Deviation trends and identify effectiuve CAPA's where necessary
  • 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 and is an IPT QRM facilitator and QRM Lead.


Requirements

  • 7 years' experience in pharmaceutical industry.
  • >5 years' experience in operation /Quality role.
  • Demonstrated technical knowledge and experience in compliance (GMP, Eng, Technical.
  • Degree in (Science/Engineering)

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