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Compliance Specialist

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Limerick
  • Sector: Other
  • Date posted: 23/02/2018
  • Job reference: J382229A

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Senior Compliance Specialist

Senior Compliance Specialist required to join a leading biotech company in the South West. The position coordinates cGMP compliance for the Facilities Department

Responsibilities: Supervisory role responsible for the coordination of cGMP compliance with all aspects of Quality for the Facilities Department.

  • Lead and manage deviation investigations, CAPAs, Change Control, Audits, and Quality Risk Management for Facilities Department issues of non-compliance.
  • Reviewing and maintain procedures, polices and other instructional documents with a focus on continuous improvement.
  • Provides support, information, and assistance to individual groups and supervisors with the initiation, review, submission, and follow-up of documents such as Change Controls, Deviations, impact statements and corrective action plans.
  • Responsible for generating and tracking Quality compliance metrics.
  • Participates in in internal, regulatory and customer audits.
  • Acts as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance.
  • Maintains knowledge of current good manufacturing practices cGMPs.
  • Responsible for periodic reviews of Facilities Department documentation and records such as logbooks, preventative maintenance records and work orders to assess for compliance with established quality standards, policies and procedures.

Education and Experience:

  • BS/BA in engineering or scientific related field with 5+ years of related professional experience in a cGMP environment or in the operation of an industrial facility.
  • Minimum of 3+ years experience working in a Compliance function in a cGMP environment.
  • Ability to work on own initiative, without direct supervision from management.
  • Team player with an ability to work well across various departments on site as well as business partners.
  • Excellent written, presentation, communication and investigation skills.

For more info contact Paul on 01 6455250 or email