Complaints Specialist

Hobson Prior is currently recruiting for a Complaints Specialist to be based in Dublin, Ireland. The position is with a large pharmaceutical company who are determined to deliver pioneering medicines to enable better health for patients around the world.

Job Responsibilities:

• Initiating, writing and managing the complaint investigation to completion.
• Receive, initiate, investigate and conclude product complaint investigations using the current product complaints management mailbox and software.
• Serve as point of contact for commercial product complaints and post market product vigilant monitoring processes.
• 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.

Key Skills:

• Strong attention to detail, good organizational skills and well-structured.
• 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.

Requirements:

• Bachelor's degree with a minimum of 2-4 years of experience in Quality Assurance or a GMP related field within Medical device, biotechnology or pharmaceutical manufacturing, or equivalent.
• Good understanding of the manufacture of combination products and the linkage to customer complaints.
• 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.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.