A global leader in the Biopharmaceutical sector are seeking a Senior Quality Compliants Specliast to join their team. The role will be fully remote with the view to adapt a hybrid working model in the near future.
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.