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.
In this role you will :
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:
Investigate and document customer complaints for pharmaceutical products to a high standard.
Conduct root cause analysis and risk assessments as part of complaint investigations.
Collaborate with cross-functional teams (Quality Assurance, Pharmacovigilance, Regulatory, Operations and Technical Team) to resolve product issues and support process improvements.
Ensure compliance with relevant cGxP regulatory requirements and internal procedures.
Prepare clear, accurate, and timely investigation reports and maintain complete records of all complaint activities.
Present findings and compliant processes during internal and external audits.
Ideal Education & Experience:
Level 8 Honours Bachelor Degree in Quality or related discipline.
3 + years' experience working in Pharmaceutical industry (Ideally in a QA role)
Excellent understanding and hands-on working knowledge of cGMP, quality and regulatory requirements.
Working knowledge and understanding of FDA, HPRA, and the pharmaceutical industry quality requirements and associated with manufacturing controls desirable
Experience in problem solving and process improvement methodologies desirable
Post Market, Complaint investigation and CAPA experience desirable
For more information on this role please contact Regina Carroll *********** or ******
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