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QA Specialist - Biopharma - 7am-3.30pm

  1. Dublin
  1. Contract
Competitive
24358WP
  1. Compliance / Quality Assurance
Date Posted23 Mar 2020
Things are still very much alive within recruitment in Dublin! and we are looking for an experienced  Quality Assurance Specialist to join this new state-of-the-art Biologics facility based in Dublin.

Could be some quite nice working hours for some - 7am - 3.30pm. (Some support may be required outside of these working hours on occasion)


Duties to include 
  • To assist in the creation, review, approval and closure of deviations, investigations, CAPAs, change controls and associated quality risk assessments in compliance with internal and external requirements
  • Identify opportunities and support continuous improvement of enterprise QMS processes and associated systems
  • Monitor QMS process performance to identify trends and best practices 
  • Author, review and approve of QMS procedural documentation and work instruction
  • Create and deliver Quality Systems training (process and technical)
  • Compile and present QMS monthly & quarterly metrics at Quality Management Review
  • System user access management
  • Participate in inspection readiness activities and internal/external audits and inspections.

Skills:   
  • 5 years’ + QA experience within the pharmaceutical industry
  • Significant, direct experience with development and approval of a minimum of two of the following: Deviations, CAPAs, Change Controls and quality risk assessments
  • In-depth knowledge of global cGxP requirements for quality systems
  • Experience working with stakeholders in pre-commercial, manufacturing, laboratory and distribution functions
  • Excellent communication skills with all levels of the organization and Health Authority representative
  • Knowledge of medical device quality system requirements desired
  • Direct experience with TrackWise desired.
  • Project Management and Lean Six Sigma certifications a plus.
  • Qualified Person designation a plus.
Education:         
  • Bachelor’s degree in a technical or life sciences discipline 
This role is based approximately 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation leads the way with state-of-the-art technology on their one of a kind manufacturing facility. 

Call me for more information on this vacancy !

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

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