About the Role:
Our client seeks a Quality Assurance Specialist to join its dynamic Quality team in Carlow. This position focuses on supporting New Product Introductions (NPI) and providing quality oversight for validation activities.
Key Responsibilities:
Provide quality oversight and direction for the introduction of new products.
Act as the site-level quality contact for internal teams and external stakeholders.
Review and approve validation documents, including cleaning validation, to ensure regulatory compliance.
Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
Review product-related documentation, such as QC Test Specifications, BOMs, and MES documentation.
Support timely closure of deviations.
Facilitate site compliance with regulatory requirements and corporate guidelines.
Collaborate with cross-functional teams, including Technical Engineering, to meet manufacturing and regulatory objectives.
Requirements:
Bachelor’s degree or higher in a related Science discipline (preferred).
3–5 years of experience in a quality role, ideally in pharmaceutical manufacturing.
Knowledge of cGMP, GDP, and regulatory requirements (Irish, European, and international standards).
Experience with equipment and process validation, particularly in sterile manufacturing.
Proficiency in Microsoft Office and relevant computer applications.
Familiarity with Lean Six Sigma methodology (preferred).
Strong decision-making, problem-solving, and collaboration skills.
For a confidential discussion and more information on the role, please contact Kevin Griffin
Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108