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QA Specialist

  • Salary: Negotiable
  • Job type: Contract
  • Location: Waterford
  • Sector: Science
  • Date posted: 13/07/2017
  • Job reference: J365832A

QA Specialist

Role Purpose:

  • Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
  • Support the development of GMP training packages and delivery of training
  • Participate in the preparation and review of procedures and batch documentation
  • Perform audits of all departments to agreed schedule
  • Ensure the quality system at Genzyme is effectively implemented and maintained

Accountability's:

  • Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues
  • Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk
  • Work with relevant departments to ensure timely closure of quality actions / findings
  • Actively contribute to continuous improvement initiatives.
  • Conduct duties in a safe manner and report all safety issues or concerns
  • Maintain work area to good housekeeping standards
  • Ensure attendance at place of work when required
  • Support team in achieving team goals/targets
  • Attend team meetings as required
  • Actively contribute to continuous improvement initiatives
  • Measure and report RFT / trend data and work with departments to resolve recurring issues
  • Participate in internal supplier and regulatory audits and key quality initiatives as appropriate
  • Perform critical/ constructive review of procedures and practices
  • Support investigation of deviations ensuring all product deviations are closed prior to product release
  • Ensure compliance to cGMP at all times

Qualification:

  • Third Level qualification essential (degree in science or related discipline preferred).

Experience:

  • Minimum of 2 years experience in a similar role
  • Experience working in a GMP environment is required
  • Excellent accuracy and attention to detail
  • Excellent interpersonal skills
  • Good presentation skills
  • Working knowledge of computer packages
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