Responsible for writing, investigating and approving product quality complaints and all related activities associated with the complaint handling program at our client 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. Escalate and participate in resolution of potential product deficiencies for all applicable client products originating from a market complaint. Liaise with Internal Stakeholders, Call Centres and service providers to ensure they support clients corporate policies and guidance while aligning with all of the necessary regulations and standards. 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.
Identify and drive continuous improvement to ensure a lean and compliant process.
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.
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 where required.
Support the departmental complaint management process through attendance of meetings to ensure on time closure of complaints.
Support line manager to meet business needs.
Represent our Client as the Subject Matter Expert (SME) for the product complaints in your name during Internal, External and Regulatory Body Inspections.
KEY SKILLS & EXPERIENCE
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.
Strong attention to detail, good organizational skills and well-structured.
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 or reports and complaint responses.
Independent, organized and able to schedule work without supervision to meet schedule deadlines.
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.
Positive and Professional attitudes towards work and colleagues
Technical/Functional (Line) Expertise
Subject Matter Expertise in assigned product platform (Small Molecule & Oncology) and a strong working knowledge of the complaints process or multiple pharmaceutical quality management systems.
Dublin, Republic of Ireland