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QA Complaints Coordinator
- Full Time
Would you like to join a Global pharmaceutical company that offer limitless potential? If the answer is yes, Team Horizon currently have an opening for a QA Complaints Coordinator to work at our client’s sterile manufacturing facility in the West of Ireland. Reporting directly into the Quality Complaints Manager, you will 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.
Why you should apply:
- Join a progressive company with a culture of diversity & inclusion who consistently features as a great place to work.
- The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.
- Excellent career progression opportunities.
What you will be doing:
- As Complaints Coordinator, you will be responsible for opening, tracking and maintain records for complaints received and data entry into complaint handling system
- We believe in collaboration so in this role, you will be 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.
- As part of this inclusive team, you will liaise with corporate QA and AbbVie Regional offices as part of the case investigation to achieve closure of complaint cases in a timely manner.
- You will ensure the development of technical product expertise to assess adequacy of complaint information and review of complaint investigations.
- As Complaints Co-Ordinator you will understand and ensure compliance with internal procedures and external global regulatory requirements.
- In this role you will actively participate in departmental Continuous Improvement project and support achievement of department goals and objectives
What you need to apply:
- Bachelor’s Degree in Science discipline
- Clear understanding of working within a regulated environment
- Proven track record in a quality discipline in the Pharma/Medical Device environment is desirable
- Knowledge of policies and regulatory requirements ensuring compliance with cGMP and ISO/FDA regulations
- Excellent communication skills
- Previous experience in the use of Trackwise, SAP and Document management systems is an advantage
- Ability to use sound judgment to make effective decisions within appropriate timeframes
- Proven to be self-directed, self-motivated and ability to prioritise competing priorities