A global leader in the Biopharmaceutical sector are seeking a Quality Compliants Specliast to join their team in Dublin.
You will be responsible for writing, investigating and approving product quality complaints and all related activities associated with the complaint handling program.
- 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 complaint's 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 the company 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.
- 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.
- 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.
- Skill in writing investigation summaries or reports and complaint responses.
To discover more about this opportunity, apply now or contact Emma Mullen at HRM on +353 87 636 9263 for a confidential discussion.