About the Role
We are seeking a Quality Assurance Specialist to join our 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.