This organisation is one of the world's leading biopharmaceutical companies, with over 10,000 employees and offices in more than 40 countries.
They have grown due to an innovative internal development pipeline and an aggressive acquisition strategy, and are now looking to hire a Senior Complaints Specialist on an initial 11-month contract basis. The role will be based at their global offices in Dublin City Centre and will work as part of an expert Market Surveillance team.
Reporting to the Associate Director, some of the Senior Complaints Specialist responsibilities will include:
- Initiating, writing, approving, and managing the complaint investigation to completion.
- Serve as point of contact for commercial product complaints and post market product vigilant monitoring processes.
- Receive, initiate, investigate and conclude product complaint investigations using the current product complaints management mailbox and software.
- Coordinate all aspects of investigation through to closure and/or provide oversight for complaint handling process.
- Apply departmental procedures to assess product complaints' impact on patient safety and product quality compliance. Assess product complaints and determine if escalation is required due to potential regulatory notification requirements.
- Liaise and collaborate with various departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc and the regional organisation.
- Liaise with external stakeholders such as CMO, Call Centres and vendors/contractors on product complaint issues. Assure that all product complaints are investigated to the appropriate level within the required timeline.
- Represent the company as the Subject Matter Expert (SME) for the product complaints in your name during Internal, External and Regulatory Body Inspections.
- Bachelor's degree with a minimum of 5-9 years of experience in Quality Assurance or a GMP related field within Medical device, biotechnology or pharmaceutical manufacturing, or equivalent.
- Working knowledge of cGMPs and other regulatory requirements governing combination drugs and device products.
- Knowledge of EU/ FDA cGMP requirements pertaining to drug/device product complaints reporting and investigation.
- Desirable experiences: combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits.
- Good understanding of the manufacture of combination products and the linkage to customer complaints.
- Ability to work independently as well as be an effective team member and leader.
- Approachable and possess the ability to forge solid working relationships with colleagues across all functions, its partners and contractors.
To learn more about this role apply online or contact Helena Boyle on + 353 1 6321870 for a confidential discussion.