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Vacancy Details


Quality Assurance Technician – Complaints - Mayo - 103604

Contract Type: Permanent
Location: Mayo
Date: 9/04/2019
Job Reference: 103604
Contact Name: Clara Burke
Contact Email:

Job Description

Quality Assurance Technician – Complaints - Mayo - 103604
Quality Assurance Technician – Complaints – Mayo

Our client, a pharmaceutical company in Mayo are currently looking to recruit a Quality Assurance Technician - Complaints for their Westport site.

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.
The Complaints – Quality Assurance Technician will liaise with corporate QA and Regional offices as part of the case investigation.

Key/Accountabilities: Weight %
This is a list of Core Duties and must not be taken as a definitive list. You may be asked from time to time to undertake other duties, either in or out of your area of responsibility.
  1. People 25% - Provide guidance to department personnel to ensure all complaints are fully investigated and suitable CAPA implemented. Liaise with corporate QA and Regional offices as part of the case investigation.
  2. Strategic 25% - Liaise with internal departments, corporate QA and Regional offices to achieve closure of complaint cases in a timely manner.
  3. Management 40% - Manage the intake, opening, tracking and maintain records for complaints received and data entry into complaint handling system.
  4. Administration/Meetings 10%
    • 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.
For example:
  • Complaint trend meetings with Business Unit Personnel
  • Departmental/ANDON Board/OPEX/Project Meetings
  • EHS
Main Contacts
  • Complaints Manager
  • Associate Director, Quality Control
  • Complaint Co-ordinators
  • Business Unit Operations Management Teams
  • QPs in Business Units
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
Education and Experience/Knowledge:
  • Proficient computer skills including: Word, Excel.
  • Excellent written and communication skills
  • Highly motivated and a self -starter
  • Ability to multi-task numerous complaints
  • Good interpersonal skills
  • Good time management and organizational skills
  • Previous experience in Pharmaceutical company
  • Bachelor Degree in Sciences or related field
  • Previous experience in the use of Trackwise and Document management systems
  • Relationship Building - Establishing excellent working relationships with cross functional teams involved in complaint investigation. Liaise with corporate QA and Regional offices as part of the case investigation.
  • Communication - Excellent communication and presentations skills, both written and oral.
  • Planning & Organising - Co-ordinate cross-functional activities in the investigation of Adverse Event/ Product Quality and customer service complaints and determination of root cause.
  • Decision Making - Identify and understand issues, problems and opportunities whilst providing a viable solution.
  • Adaptability - Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
  • Passion for results: - Understand and ensure compliance with internal procedures and external global regulatory requirements
  • Receptivity to feedback - Receptive to the ideas of others and welcome and accept constructive feedback, display humility where appropriate.
  • Culture fit - Upholding the values and ethos of the company
  • Other requirement (i.e. travel) - Undertake any training or travel that the role may require

For further information on this Quality Assurance Technician – Complaints in Mayo please contact Clara Burke on 086-8168273/
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