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Details

Technical Writer Senior Associate


Reference:PORA006697 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Nurse Associate, Quality Specialist

A Senior Associate Technical writer – Supply Chain is required to join a leading global Biopharmaceutical business in Dublin. The role will be responsible for leading, coordinating, contributing to and undertaking activities pertaining to Supply Chain Deviations, Corrective/Preventive Actions and Change Controls.

The role will provide technical expertise with a focus on Compliance and Continuous Improvement while implementing a Lean Culture and Right First Time (RFT). The role also represents the Supply Chain unit by liaising with internal and external customers. Primary responsibilities include managing the Supply Chain aspect of the Deviation, Investigations and Change.

Responsibilities

  • All activities within the Quality System associated with Supply Chain Deviations, CAPA records and Change Controls
  • Lead, contribute to, oversee, run and participate in Root Cause Analysis, implementing improvements and Corrective Actions
  • Develop, review and update Supply Chain Standard Operating Procedures
  • Develop protocols for execution in Supply Chain in support of change controls, non-conformances & troubleshooting investigations with support from relevant SMEs
  • Trend analysis of Deviations relating to Supply Chain
  • Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information and performance via scorecards and meetings
  • Perform tasks and participate on project teams assigned to assist in the timely completion of activities associated with the attainment of group, departmental, team and corporate goals
  • Ensure timely completion of Supply Chain Deviations, CAPAs and change controls utilizing the appropriate procedures and Quality Management Tracking System (QMTS)

The Person

  • Experience with Deviations, CAPAs, Change Controls and audits
  • Hold a third level qualification in science related discipline
  • Have a minimum of 5 years' experiencein pharmaceutical/healthcare
  • Possess key competencies to include planning/organization, problem solving, communication, teamwork, flexibility, coaching and motivating
  • Excellent verbal and written communication skills including technical writing, presentation and facilitation skills
  • Experience in interacting with regulatory agencies including written responses






If you would like further Information you can contact the recruiter directly:



Paula O'Reilly | Tel: +353 (0) 1 507 9265