Our client, a pharmaceutical company in Mayo are currently looking to recruit a Quality Assurance Technician - Complaints for their Westport site.
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.
- 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.
- Strategic 25% - Liaise with internal departments, corporate QA and Regional offices to achieve closure of complaint cases in a timely manner.
- Management 40% - Manage the intake, opening, tracking and maintain records for complaints received and data entry into complaint handling system.
- 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.
- Complaint trend meetings with Business Unit Personnel
- Departmental/ANDON Board/OPEX/Project Meetings
- Complaints Manager
- Associate Director, Quality Control
- Complaint Co-ordinators
- Business Unit Operations Management Teams
- QPs in Business Units
- 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.
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/ firstname.lastname@example.org
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