Senior Technical Writer Associate

09 Oct 2019

The role will provide technical expertise with a focus on Compliance and Continuous Improvement

Senior Technical Writer Associate- Pharmaceuticals- Dublin

Job purpose:

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, 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. The role may involve carrying out additional work functions that are not described in this specification but are associated with the role. Primary responsibilities include managing the Supply Chain aspect of the Deviation, Investigations and Change Control process to ensure requirements are met and issues are addressed, and a cycle of continuous improvement is in place

Key Responsibilities:

  • All activities within 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)
  • Provide technical guidance
  • Ensure flow of communication to stakeholders
  • Apply expertise and critical thinking to independently resolve issues
  • Be responsible for specific programs and/or projects
  • Participate in Regulatory Inspections

Education and Experience:

  • Hold a third level qualification in science related discipline
  • Have a minimum of 5 years' experience in pharmaceutical/healthcare
  • Possess key competencies to include planning/organization, problem solving, communication, teamwork, flexibility, coaching and motivating
  • Advanced experience and capability with MS Office application
  • Apply analytical thinking to evaluate and interpret complex situations/problems using multiple sources of information
  • Anticipate and prevent potential problems
  • Excellent verbal and written communication skills including technical writing, presentation and facilitation skills
  • Strong ability to lead teams and effectively utilize team resources
  • Experience in interacting with regulatory agencies including written responses
  • Experience with Deviations, CAPAs, Change Controls and audits
  • Ability to evaluate complex compliance issues
  • Ability to work in a fast-paced environment with changing priorities
  • Work under minimal direction

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

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