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Senior QA Officer, Waterford



Waterford, Ireland 

Job Category:

Biotech/Pharma, Science

EU work permit required:


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Job Description:

The Opportunity

Team Horizon is seeking a Senior QA Officer to support the R&D Quality Assurance Team Lead & Head of Quality with the development, implementation and maintenance of the quality standards and systems to ensure that products comply with procedures, specifications and cGMPs

The Role

  • To ensure project plans and milestones are delivered according to agreed timelines.
  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • To ensure review of all QC and production batch documentation when required and correctly in order to achieve a high level of customer service and cGMP.
  • Mentoring - support company with problem solving and skill development to aid learning and early problem resolution.
  • Ensure that Vendor Management program is adhered to and Lead vendor audits of GxP services as required
  • Ensure that all customer requests are dealt with within a reasonable timeframe.
  • Review batch documentation in a comprehensive and timely manner.
  • Participate in outside Inspections (Customer audits / Regulatory inspections)

The Person

  • Qualified to a minimum of degree level, preferably a Science degree incorporating Quality Assurance
  • 4 years’ experience working in a Quality Assurance role in a manufacturing environment an advantage.
  • Lead Auditor qualification an advantage
  • People management skills
  • Working knowledge of EDMS (Electronic Document Management System) and ERP (Enterprise Resource Planning)
  • Project management
  • Ability to deal with cross-functional groups

Employment Type:

Full time
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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