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QA Specialist

  1. NI & Ireland
Dublin 16
  1. Contract
Competitive
  1. Compliance / Quality Assurance
09-04-2020
24358 JL

This vacancy has now expired

QA Specialist required for a world Leading bio tech organization who are at a Peak phase in establishing an innovative and industry leading manufacturing facility in Dublin Ireland.
 Working in their state of the art  manufacturing suites, the QA Specialist will be responsible for   CAPAS, change controls and QMS maintenance.
  • Contract Length:          12 month
  • Hours:                         40 per week
    **Standard hours for this role are 7am - 3:30pm.  Support outside of these hours may be required on occasion**

Duties to include but not limited to:
  • Use deep process knowledge and experience to assist 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
  • Proactively identify opportunities and support continuous improvement of enterprise QMS processes and associated systems
  • Lead completion of assigned projects with cross-functional stakeholder teams.
  • On-time completion of assigned project
  • Monitor QMS process performance to identify trends and best practices on an ongoing basis (audits, visual management systems, dashboards, status reports etc.
  • Author, review and approve of QMS procedural documentation and work instruction
  • Create and deliver Quality Systems training (process and technical)
  • Compile, analyze and present QMS monthly and quarterly metrics at Quality Management Review
  • System user access management
  • Participate in inspection readiness activities and internal/external audits and inspections.
  • Other duties required to support the growing Quality organization as assigned.
Skills Required
  • 5 years’ + QA experience within the pharmaceutical industry or related field
  • 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
  • Demonstrated critical thinking and problem solving skills
  • Demonstrated ability to lead cross functional (pre-commercial, manufacturing, laboratory and distribution functions) teams to achieve project objectives
  • High level of organization and attention to detail to plan, execute and track completion of deliverables
  • Able to prioritize and manage workload and manage shifting priorities based on criticality to ensure commitments are met
  • 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.
  • Bachelor’s degree in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology)
 
 Please apply now with you CV to be considered for this long-term opportunity.

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

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