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Contact Info
Paula O'Reilly
Life Science

+353 1 507 9265
[email protected]
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Details

Compliance Analyst / Senior Compliance Analyst


Reference:POR623344 Location: Limerick
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Analyst

An IT Compliance Analyst / Snr IT Compliance Analyst is required to join a rapidly expanding Global Biopharmaceutical business in Limerick. This is an opportunity to develop your career with an award-winning business that develop life-changing medicines for serious diseases. The compliance Analyst is responsible for ensuring that the IT group is operating in compliance with regulatory requirements and internal procedures as well as being the key contact between the IT and Quality Assurance groups.

The Role

  • Ensures IT personnel are operating in compliance with regulations and procedures.
  • Assists IT personnel in interactions with Quality Assurance personnel and the Quality Management System.
  • Evaluates, develops and modifies Policies and Standard Operating Procedures to meet regulatory and corporate requirements and obligations.
  • Tracks and reports on IT Quality metrics.
  • Works closely with QA Validation to ensure IT systems are validated and maintained in a validated state.
  • Represents IT or assists IT Subject Matter Experts (SMEs) during internal and external audits.
  • Ensures operational controls are in place and maintained throughout the system lifecycle (e.g. periodic reviews, disaster recovery testing, performance monitoring etc.).
  • Tracks and verifies that all IT Quality instance activities are completed in a timely manner.
  • Supports IT personnel in writing/responding to deviations/CAPA's/Change Controls and other quality instances.
  • Assists IT personnel in creating/updating and approval of documents in the electronic document management system.
  • Take ownership for technical writing of IT deviations/CAPA's/Change Controls and other quality instances.
The Person
  • BS/BA in related field required.
  • Analyst - Minimum of 2 years of relevant experience in the Life Science industry sector
  • Senior - Minimum of 5 years of relevant experience in the Life Science industry sector
  • Quality Assurance (QA) experience
  • Strong Technical Writing Skills



For further details please contact; Paula O’Reilly on 087 7094141 or send CV in confidence to [email protected]