We are seeking a highly motivated Quality Systems professional to join our multinational organization in Ireland.
The Role
* Support the development and implementation of quality systems across Drug Substance and Drug Product facilities.
* Drive continuous improvement initiatives to enhance quality performance metrics.
* Serve as the subject matter expert for validation activities across both operations.
* Participate in key committees including PVC, WVC, CVG, and EQVC.
* Approve validation documentation and support capital projects aligned with quality objectives.
* Maintain validated states post-change and develop summary reports and quality plans.
* Provide QA oversight for laboratory systems, documentation, and incidents.
* Approve stability reports and support OOS investigations.
* Act as the Microbiology QA point of contact for water, utilities, environment, and product-related issues.
* Own and maintain critical documents such as the Site Master File, Validation Master Plan, and key procedures.
* Oversee Annual Review and Quality Agreement systems.
* Approve user access reviews and site application controls.
* Participate in internal audits, customer complaints, and supplier change evaluations.
* Support regulatory inspections and license/filing documentation requests.
* Manage returned goods disposition in line with quality requirements.
Educational and Experience Requirements
* A degree or post-graduate qualification in Science, Pharmacy, or Engineering is required.
* 3+ years' experience in a regulated pharmaceutical manufacturing environment is preferred.
* Experience with quality system ownership, validation, and regulatory audit support is highly desirable.
* Proficiency in quality management systems such as Veeva, SAP, LIMs, and Trackwise is beneficial.