Job Description:
An Associate Specialist, Quality Assurance role is available at our site in Carlow. The ideal candidate will be responsible for ensuring compliance with cGMP and regulatory requirements during drug product manufacture.
Key Responsibilities:
* Review and approval of GMP documentation to support corporate compliance and regulatory expectations.
* Ensure objectives are achieved consistent with Merck's requirements for compliance, safety, and reliable supply.
Documentation:
* Review and approval of manufacturing batch documentation, SOPs, and other documents as necessary.
* Drive effective writing, revising, and rolling out of accurate operational procedures and training materials.
* Support the development and implementation of improved quality reporting measures.
Quality Oversight:
* Work collaboratively to drive a safe and compliant culture.
* Provide quality input into decision-making processes on the shop floor.
* Provide training in all aspects of Quality Management Systems and GMP.
Continuous Improvement:
* Partner with colleagues to provide support and advice on day-to-day operations and project work.
* Initiate and maintain Quality related metrics to ensure ongoing monitoring and follow-up.
Requirements:
* Third Level Degree qualified in a Science/Technical or related discipline.
* Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
* Knowledge of US and European cGMP guidelines, and other international regulatory requirements.