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Senior Compliance Specialist

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Limerick
  • Sector: Science
  • Date posted: 15/02/2018
  • Job reference: J381779A

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Senior Compliance Specialist

Our client, a leading Biopharmaceutical organisation is currently seeking a Senior Compliance Specialist to join their expanding team. In this position you will be tasked to supports the Process Validation and Manufacturing Support group within the Process Sciences department by providing oversight for all aspects of cGMP compliance. You will be part of a dynamic scientific and technical team in a fast-paced environment and work closely with cross functional teams.

Essential Duties and Responsibilities may include, but are not limited to, the following:

  • Manage product impact assessment (PIA) request process, PIA allocation to team members and track PIAs progress.
  • Monitor and Track progress of all MFG Support group owned quality records, such as deviations, Change controls and CAPAs.
  • Strong communicator to represent team at cross functional quality meetings
  • Be a SME for quality records and quality systems, ensuring consistency of records.
  • Train and promote technical writing and quality awareness
  • Maintain and communicate appropriate metrics
  • Review team owned quality records for compliance and accuracy
  • Represent PS at daily & weekly cross functional notice of event meetings
  • Develop an effective compliance framework for the Process Sciences department through the development and implementation of appropriate compliance related policies and procedures.
  • Act as a liaison between the MFG Support group and onsite quality and regulatory groups to define and address all issues of non-compliance.
  • Drive proactive compliance environment in the MFG Support team through knowledge transfer and education of compliance related items.
  • Coordinate/perform training for MFG Support personnel on regulatory and quality topics

Education and Experience:

  • Highly desirable for a scientific and quality background
  • Requires BSc/Masters in scientific discipline or related field with 6+ years of relevant work experience in pharmaceutical or related industry.
  • Minimum of 4+ years' experience working in a Compliance function in a cGMP environment.
  • Excellent communication skills with the ability to engage with a diverse range of individuals across all levels of the organization.
  • Strong Technical writing ability.
  • Proficient in MS Office (Word, Excel, Outlook, Access and PowerPoint)

For more information on this and similar position please contact Kathryn on 01 6455244 or email