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QA Validation Compliance Specialist

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Limerick
  • Sector: Science
  • Date posted: 16/02/2018
  • Job reference: J381859A

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QA Validation Compliance Specialist

Our client, a leading Biopharmaceutical organisation is currently seeking a QA Validation Compliance Specialist to join their expanding team. In this position you will be tasked to maintain compliance of the QA Validation cGMP Compliance, Training and Audit function for the QA Validation Department.

The Compliance Specialist will be part of a dynamic team in a fast-paced environment and work closely with multiple teams, assist with the development of processes and systems that drive compliance to critical regulatory requirements and site expectations.

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

  • Provide support, information, and assistance to individual groups and supervisors with the initiation, review, submission, and follow-up of documents such as CCs, NOEs, EOEs and CAPAs.
  • Provide tracking and trending for all QA Validation related compliance activities i.e NOEs, EOEs, CAPAs, Change Controls, Audit Actions etc.
  • Generate weekly/monthly management reports for compliance metrics
  • Supports the development and implementation of appropriate compliance related policies and procedures for QA Validation.
  • Reviews procedures, policies and other instructional documents relating to QA Validation to ensure compliance with company policy and local and international regulatory requirements
  • Coordinate training requirements for QA Validation personnel on regulatory and quality topics such as good documentation practices.
  • Act as department Compliance representative for QA Validation when collaborating with functional departments to resolve issues and maintain compliance
  • Actively participate in continuous improvement initiatives.
  • Participates in the preparation and support of regulatory and customer audits.
  • Keeps current on changes to all regulatory requirements and, with other members of the Quality team, facilitates implementation into Regeneron systems
  • Training of QA Validation personnel on related disciplines within QA Validation
  • Participate in investigations and root cause analysis for all QA Validation Department issues of non-compliance.
  • Work with cross-site teams to support standardization of QA Validation practices.
  • Follow current good manufacturing practices (cGMPs).
  • Promotes a GxP and Quality mindset at all levels.
  • Ability to easily adapt to changing needs of the company.

Education and Experience:

  • Requires BSc/BA in scientific discipline or related field with 3+ years of relevant work experience in pharmaceutical or related industry, in a cGMP environment. Additional related work experience will be substituted for educational requirement. Quality and/or Validation experience essential.
  • Understanding of technical terminology commonly used in association with daily operations of a facility and the ability to use the terminology, in context, when discussing issues or generating documentatio

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