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Senior Compliance Specialist

Job Title: Senior Compliance Specialist
Contract Type: Permanent
Location: Cork
REF: 91068
Job Published: about 1 month ago

Job Description

Contact: Anne Gough
Telephone: 0860449473

Senior Compliance Specialist
Our client, a medical device company in Cork are currently looking to recruit a Senior Compliance Specialist for their site.

  • The Senior Compliance Specialist helps to moulds 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 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.
  • 5 years' experience in pharmaceutical industry.
  • >3 years' experience in operation /Quality role.
  • Demonstrated technical knowledge and experience in compliance (GMP, Eng, and Technical.
  • Degree in (Science/Engineering)
  • Core Competencies
  • MMD and site quality policies, procedures and guidelines
  • Relevant GMP standards
  • The Quality System
  • Site procedures and policies
  • Understands key business drivers and uses this knowledge to make decisions and prioritise
  • Must possess a high standard of knowledge and skills in the following areas:
  • Communication skills both written and oral including persuading others
  • Technical report writing
  • Time management
  • Problem solving skills applied to issue identification and resolution
  • Continuous improvement skills:
  • Interpersonal Team membership and leading Skills e.g.: Listening, integrating diverse perspectives, adds value to the achievement of team goals.
  • 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, and PowerPoint.
  • Demonstrate the ability to coach and influence others within the Vaccine IPT
  • Organisation 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
For further information on this Senior Compliance Specialist role in Cork please contact Anne Gough on 0860449473 /
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