Job Overview
The Quality Assurance Specialist will play a crucial role in assessing and enhancing the Quality System to ensure Good Manufacturing Practice (GMP) compliance and the quality of pharmaceutical products.
They will provide quality assurance support and advice to various operational departments, interacting with both internal and external customers to meet project timelines while maintaining high standards of product quality and compliance.
Key Responsibilities:
* Assist in implementing and continuously improving quality systems such as deviation and CAPA management, change controls, and risk assessments.
* Monitor and review quality system elements, including deviation reports, corrective and preventative actions, change controls, complaints, audits, and out-of-specification reports.
* Review data related to secondary packaging activities and validation reports to ensure accuracy and compliance.
Requirements
* Eligibility to work in IE or valid work permit allowing full-time employment in IE.
* Degree in Life Science or closely related field or significant EU GMP experience working within Pharmaceutical Industry in Quality role.
* Significant EU GMP experience working within established Quality System.
* Comprehensive knowledge of regulatory requirements for pharmaceutical products including familiarity with Good Manufacturing Practice, Pharmaceutical Quality Systems, Quality Risk Management, and Pharmaceutical Product Lifecycles.