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Senior Compliance Specialist

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Cork
  • Sector: Science
  • Date posted: 21/06/2018
  • Job reference: J388475A

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Senior Compliance Specialist

The role will offer the successful candidate a unique opportunity to work as part of the Vaccine IPT team.

The Operational Compliance Specialist will work with the Integrated Process Team (IPT) compliance group to maintaining all aspects of compliance within the Vaccine IPT team. This includes GMP& EHS compliance. The leadership style is one of collaboration, coaching. This will require a substantial amount of his/her time within the various areas, engaging and communicating with all team members.

Responsibilities

  • 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 effective CAPA's where necessary
  • Member of the site PIR team works with the Vaccine IPT to ensure that the 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 and is an IPT QRM facilitator and QRM Lead.

Qualifications

  • 5 years' experience in pharmaceutical industry.
  • >3 years' experience in operation /Quality role.
  • Demonstrated technical knowledge and experience in compliance (GMP, Eng, Technical)
  • Degree/MSc in (Science/Engineering)

Skills/Competencies

  • MMD and site quality policies, procedures and guidelines
  • Relevant GMP standards
  • The Quality System
  • Site procedures and policies

Interested?

Do not hesitate to reach out to Jack on 01 6455262 or jack.conway-kenny AT experis.ie

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