Quality Systems Specialist Job Overview
We are seeking an experienced Quality Systems Specialist to support the Quality Systems activities in our Drug Substance and Drug Product facilities.
This is a contract position for 11 months, located in Tipperary.
The ideal candidate will have a degree or post-graduate qualification in Science, Pharmacy, or Engineering, and at least 3 years of experience in a regulated pharmaceutical manufacturing environment.
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Duties and Responsibilities
* Support the implementation and maintenance of quality systems to ensure compliance with regulatory requirements.
* Drive continuous improvement initiatives to enhance quality performance metrics.
* Serve as a subject matter expert for validation across Drug Substance and Drug Product operations.
* Participate in cross-functional committees to align on quality strategies.
* Approve validation documentation and support capital projects.
* Maintain validated state 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 key procedures and Site Master File.
* 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 site regulatory inspections and license/filing documentation requests.
* Manage returned goods disposition in line with quality requirements.
* Lead scheduling, minutes, and follow-ups for monthly Quality Council meetings.
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Requirements
* A degree or post-graduate qualification in Science, Pharmacy, or Engineering.
* At least 3 years of experience in a regulated pharmaceutical manufacturing environment.
* Experience with quality system ownership, validation, and regulatory audit support.
* Experience in quality management systems such as Veeva, SAP, LIMs, Trackwise.
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If you are interested in this opportunity, please contact Rachel Kent at Life Science Recruitment for further information.