Compliance Specialist

  • Cork
  • Temporary 12 months
  • JO-1905-64492_1564583625

Summary

Responsibilities:

  • Supports the compliance plan and quality metrics generation
  • Complete review and approval of documentation
  • Leads walk down and support audits
  • Participate in the preparation for and hosting of regulatory and customer audits
  • GMP training delivery to personnel
  • Investigation of Minor Deviations
  • Provide Compliance guidance to Operating procedure
  • Review Deviation trends and identify effective CAPA's where necessary
  • Member of the site PIR team works with team to ensure that the department is 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.

Requirements:

  • 4 years' experience in pharmaceutical industry.
  • >2 years' experience in operation /Quality role.
  • Demonstrated technical knowledge and experience in compliance (GMP, Eng, Technical.
  • Degree in (Science/Engineering)

Skills:

  • Communication skills both written and oral including persuading others
  • Technical report writing
  • Time management
  • Problem solving skills applied to issue identification and resolution
  • Responds to non-standard requests
  • Supports cross functional investigations
  • Timely decision making.
  • Demonstrated initiative and pays attention to detail
  • Good presentation skills. Advanced PC skills such as Excel, Word, PowerPoint.
  • Demonstrate the ability to coach and influence others
  • Organization Skills: Ability to manage multiple priorities and to know when to escalate issues for resolution
  • Proven ability to work as part of a highly motivated team member

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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The Life Science Specialists

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