Senior Quality Specialist ***Cork***
Our client is a leader in healthcare and will give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.
This is a Quality role in complaints investigation and will be responsible for investigating customer complaints related to pharmaceutical products, ensuring thorough documentation of findings.
The role requires high attention to detail, excellent documentation skills, and the ability to work independently and collaboratively across teams.
The successful candidate will support the maintenance of quality standards and regulatory compliance, contributing to continuous improvement in complaint handling processes.
Key Responsibilities:
Review and approve all complaints investigated by the Complaints Investigator.
Ensure complaint investigations meet regulatory and internal quality standards.
Review complaint metrics and identify trends for continuous improvement.
Collaborate with the Pharmacovigilance team to ensure accurate reporting and compliance.
Prepare and present complaint metrics for management review and quality meetings.
Support audits and inspections by providing approved complaint documentation.
Participate in training programmes, including an initial ***** week period in Farnham, UK.
Maintain up-to-date knowledge of pharmaceutical quality systems and regulatory requirements.
Support continuous improvement initiatives in complaint handling and documentation
Ideal Education & Experience:
Level 8 Honours Degree in a technical, scientific, or quality discipline.
Minimum 5+ years' experience in a pharmaceutical quality, compliance, or complaints management role.
Proven experience in reviewing and approving complaint investigations within a regulated environment.
High attention to detail and excellent documentation skills.
Familiarity with HPRA, FDA, and other regulatory agency requirements.
Previous experience presenting complaint metrics during audits or management reviews.
For more information on this role please contact Regina Carroll *********** or ******.
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