The position of Product Complaints Coordinator requires the efficient, consistent and high quality management of product quality complaints across all divisions
Product Complaints Coordinator-Medical devices-Dublin
Our client requires a talented, motivated and enthusiastic individual to join their Regulatory Affairs team. The position of Product Complaints Coordinator requires the efficient, consistent and high quality management of product quality complaints across all divisions (medicinal products and medical devices) and is currently for a two-year contract.
- Management of product complaints for products on the Irish market, from initial receipt through to closure, in conjunction with the company's Global Complaints Departments and in accordance with all relevant EU legislation, HPRA Guidelines and company specific Standard Operating Procedures.
- Document and maintain the complaint files for all reports received.
- Prompt communication of every complaint received to the Global Complaints Department and escalate serious product complaint issues, as necessary, to the relevant people both locally and globally, within the required timeframes.
- Liaise with customers, in collaboration with the Sales/Marketing teams, regarding product quality issues and also in relation to medical/technical/clinical queries, ensuring an accurate and prompt response.
- Review the product complaint investigation reports and document letters for the customers to relay the investigation results.
- Provide periodic training, as required, to all relevant personnel on the handling of product quality complaints.
- Contribute to the documentation and review of local procedures for product quality complaints.
- Attend and partake in internal and external audits related to your job.
- Support Pharmacovigilance, Medicovigilance and Compliance activities as directed when required.
Skills & Experience Requirements:
- A degree in a life science or pharmacy discipline.
- 2 years work experience in a compliance environment and a good understanding and working knowledge of GxP.
- Familiarity with relevant Legislation, Regulations and Guidelines applicable in Ireland and the EU.
- Proficiency in the English language with strong verbal and written communication skills is essential.
- Ability to process technical information.
- Accuracy and excellent attention to detail.
- Excellent organisational skills.
- Good interpersonal skills.
- Computer skills (Microsoft Word, Excel; SAP an advantage).
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.