Quality Assurance Technician (Complaints)

JOB SUMMARY:

The Complaints – Quality Assurance Technician, will report directly to the complaints manager and coordinate the handling of customer complaints investigations, trending and analysis for all commercial & clinical products, working with internal departments on Root Cause Problem Solving cases to ensure implementation of robust Corrective/Preventive action plans and tracking these to completion. The Complaints – Quality Assurance Technician is responsible for opening, tracking and maintain records for complaints received and data entry into complaint handling system.  The Complaints – Quality Assurance Technician is responsible for coordinating cross-functional activities in the investigation of Adverse Event/ Product Quality and customer service complaints and determination of root cause including the coordination of laboratory testing of complaint samples.

You will liaise with corporate QA and company Regional offices as part of the case investigation.

KEY/ACCOUNTABILITIES:                                                                                          

  • Provide guidance to department personnel to ensure all complaints are fully investigated and suitable CAPA implemented. Liaise with corporate QA and company Regional offices as part of the case investigation.
  • Liaise with internal departments, corporate QA and company Regional offices to achieve closure of complaint cases in a timely manner.
  • Manage the intake, opening, tracking and maintain records for complaints received and data entry into complaint handling system.
  • Complaint trending and monthly reports
  • Quality Defect reports relating to customer complaints/counterfeit cases
  • Attend all meetings as requested by the Complaints Manager or arrange an appropriate deputy.
  • Supporting the preparation of documentation on adverse events and quality defects received through the complaints system to ensure timely submission to relevant regulatory agencies.  Develop technical product expertise to assess adequacy of complaint information and review of complaint investigations.
  • Support complaint trend analysis and issuance of key reports to relevant departments.
  • Understand and ensure compliance with internal procedures and external global regulatory requirements.
  • Actively participate in departmental Continuous Improvement project and support achievement of department goals and objectives.

KEY REQUIREMENTS

  • Proficient computer skills including: Word, Excel.
  • Excellent written and communication skills
  • Third Level Qualification
  • Highly motivated and a self -starter

For further information contact Maria on 094 9029944 and email CV maria@arconrecruitment.com

Your Recruitment Consultant is Maria

Maria
Maria is a Senior Recruitment Consultant with Arcon Recruitment. Maria is responsible for developing relationships with new and existing companies and assisting them with all aspects of their recruitment requirements.