Our Client, a global leader in medical technology, are seeking a dedicated and detail-oriented Quality Specialist to join our team in Dublin.
As part of their commitment to improving patient care and ensuring the highest standards in healthcare solutions, you will play a critical role in maintaining and enhancing the quality of our products and processes.
This position offers the opportunity to work in a dynamic and innovative environment, where your expertise will contribute to ensuring compliance with regulatory standards and delivering superior quality products that make a difference in people’s lives.
If you are passionate about quality assurance, enjoy problem-solving, and thrive in a collaborative setting, this role could be your next exciting career move!
Key Responsibilites:
- Provide support to the Quality Manager, Responsible Person, and Qualified Person in ensuring adherence to GMP and GDP standards, along with Quality Systems, procedures, and applicable regulatory and industry standards.
- Assist with the Quality Department's continuous improvement initiatives, ensuring compliance as the company expands its compounding services.
- Collaborate with staff to define and periodically review Quality Procedures to maintain adherence to GMP and GDP guidelines.
- Prepare data and reports for Quality Review Board presentations.
- Support the execution of internal audits, evaluate corrective and preventive actions (CAPA), and monitor their effectiveness.
- Deliver training on GMP/GDP updates to ensure team-wide compliance with the Quality Management System (QMS).
- Record and investigate deviations and incidents, reporting findings to the Quality Manager and Qualified Person.
- Aid Process Owners in risk assessment and implementing necessary corrective measures.
- Perform Supplier Audits and Assessments as needed.
- Ensure timely documentation and management of change controls.
- Provide support for Pharmacovigilance and Medicovigilance activities as required.
- Issue and track protocol/report numbers and maintain related logs.
- Compile and submit required reports promptly.
Key Skills:
- Bachelor's degree in a relevant scientific field preferred.
- Proven experience supporting quality systems in the pharmaceutical sector.
- Familiarity with EU pharmaceutical regulations and GMP/GDP requirements.
- Experience working in a MIA-regulated environment, ideally with third-party warehouse distribution.
- A minimum of 3 years’ experience in a regulated pharmaceutical setting, particularly in a quality role within a manufacturing site.
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