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Automation Technical Writer

  1. West
  1. Contract
  1. Compliance / Quality Assurance
Date Posted18 Mar 2021

This vacancy has now expired

Technical Document Writer required to join the Automation Team within a global Bio-pharmaceutical Organisation based in the picturesque Munster region of Ireland. 

This role will be a site based position with some flexibility to work from home a couple of days per week; working from home flexibility to be agreed with Line Manager. 

We are looking for someone with a strong Compliance background within a GMP manufacturing environment for this role. 

Essential Duties and Responsibilities include, but are not limited to the following:
  • Responsibility for ensuring compliance with all aspects of Quality for the Automation team. 
  • Manage Deviations, CAPA, Change Control, Audits, and Quality risk management.
  • Reviewing and maintain procedures, polices and other instructional documents with a focus on continuous improvement.  
  • Provides periodic reviews of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, preventative maintenance records/work orders, etc
  • Responsible for the approval of deviation notification, driving deviation investigation and tracking implementation through to closure of associated corrective action.
  • Responsible for generating and tracking Quality compliance metrics
  • Responsible for generating and maintaining Life cycle document across automation platforms

Desired Experience:
  • Experience working with validated Automation systems in the pharmaceutical manufacturing environment.
  • Direct experience and in depth knowledge of automation platform desirable.
  • Ability to work on own initiative, without direct supervision from management.
 To be considered for this position, please apply with a copy of your up to date CV today! 

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

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