Quality Complaints Specialist – 12 Month contract – Dublin
Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as a Quality Complaints Specialist to work with a well-known Pharmaceutical company. This is a contract role initially for 12 months and will be based in Dublin.
The Quality Complains Specialist will be responsible for writing product quality complaints and all related activities associated with the complaint handling program, per corporate procedure and regulatory standards including goal setting in-line with corporate strategy and priorities and the GQ road map. The scope of responsibility encompasses timely management of the complaint processes to comply with corporate procedures, EU and FDA regulations, ISO13485 and other regulatory requirements as applicable. Serve as the Quality liaison between individuals and business units within or outside the organization regarding matters related to product complaint activities, including risk management, regulatory inspections and complaint handling processes for all applicable products.
- Initiating, writing and managing the complaint investigation to completion.
- Serve as point of contact for commercial & clinical product complaints and post market product vigilant monitoring processes
- Receive, initiate, investigate and conclude product complaint investigations using the current product complaints management software and coordinate all aspects of investigation through 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.
- Interface and collaborate with various departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc and the regional organisation. Interface 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.
- Send customer response letters.
- Represent as the Subject Matter Expert (SME) for the product complaints in your name during Internal, External and Regulatory Body Inspections.
- Drive continuous Improvement to ensure a lean and compliant process
Desired Skills and Experience
- Bachelor’s degree preferred with significant relevant experience in Quality Assurance or a GMP related field within Medical device, biotechnology or pharmaceutical manufacturing.
- 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.
- Has a systematic way of working, prioritizing tasks based on risk or criticality – seeking effective solutions within the complexity that surrounds product complaints.
- Excellent troubleshooting and problem-solving skills.
- Skill in writing investigation summaries and complaint responses.
- Ability to work independently as well 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.