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QA Compliance Specialist

  1. Dublin
Dublin
  1. Contract
Competitive
  1. Compliance / Quality Assurance
07-04-2021
26601/NK

This vacancy has now expired

QA Compliance Specialist required in Dublin for a leading Biopharmaceutical organisation

Hours: 40 hours per week, 8 hours per day
Initially remote role due to Covid restrictions, but long-term plan is to be back onsite/ remote mixed. Therefore we are looking for Irish Locals for this position. 

About the role: 

Sr. Specialist, Quality Systems, required to join the Central Quality Systems and Compliance team. This role will interface globally with users across Global Operations, Country Operations, Research & Development, IT and Quality Operations to support execution and monitoring of the enterprise Quality Management System (QMS) governing Deviation, CAPA and Change Control.


 The ideal candidate will have the following experience:
  • Strong experience in Quality within the pharmaceutical industry
  • Prior experience in a Global QA role strongly preferred.
  • Direct experience with development and approval of deviations, CAPAs and Change Controls.
  • Knowledge of global GCP, GLP, GVP, GMP and GDP requirements for quality systems, medical devices and combination products.
  • Direct experience with TrackWise desired
Principal Responsibilities to include:
  • Assist global GxP business partners with the creation, review, approval and closure of deviations, investigations, CAPAs, change controls and associated quality risk assessments in compliance with internal and external requirements.
  • Create and deliver QMS training (process and technical).
  • Create and update of QMS procedural documentation and work instructions.
  • Extract and compile QMS data into reports for metrics and analysis.
  • Completion of assigned projects and participation on global and local project teams, supporting delivery on time and in full.
  • Participate in inspection readiness activities and internal/external audits and inspections.
 For more information on this position, please apply with a copy of your updated CV today! 



The candidate must have the rights to work in the location stated in the job advert.

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