• 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 escalation of 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.

• 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).

• Conduct scientific studies. Analyze data and processes; develop, characterise and make formal recommendations.
• Plan and execute experiments using design of experiment techniques
• Coordinate and assist the formal creation of system test methods in conjunction with the Quality and Regulatory Groups
• Reengineer existing processes or test methods to adapt to changes in market, business, and/or regulatory requirements.
• Transition products and processes from development phase to routine production
• Work within cross functional teams to identify key project/process or performance attributes and opportunities for product and process improvements.
• Coordinate and lead technical root cause investigations.
• Cooperate with other functional areas and groups within the company to achieve robust product supply
• Participate in Product transfer activities within the company
• As required lead reagent & system complaint investigations within the company and subsequent report handling.
• Adherence to the quality system and training given at all times
• Completion and review of Documentation to cGMP/GDP requirements/standards.
• Work constructively with team members from R&D, Continuous Product Improvement,  Marketing, Operations, Quality Assurance, Technical Support, Clinical Affairs, Customer Service, and Finance.
• Work constructively with team members from the company on multi-site projects
• Communicate progress on a frequent basis. Communication will require the successful candidate to present project updates to the relevant stakeholders

• An advanced life science degree.
• Laboratory experience in biological sciences required
• Demonstrated competence in biochemical techniques and statistical concepts.
• Experience in the field of Coagulation/ IVD industrial of ≥2 years would be advantageous.
• Ability to read, analyze, and interpret technical data, and technical procedures.
• Excellent attention to detail and the ability to work well alone and as part of a team.

Role Description