PE Global are currently recruiting for a Quality Specialist – Quality Systems , for a client site in Tipperary. 11 month initial contract – hybrid Position Summary The Contract Associate Quality Specialist is responsible for supporting day-to-day Quality Assurance activities at the Ballydine facility and serves as an integral member of the Quality Systems Centre of Excellence (CoE) Team.
This role ensures robust compliance with global quality and cGMP standards, supports core site quality systems, and actively contributes to continual improvement initiatives across the site. Operating within a fast-paced environment, the successful candidate will apply strong quality systems knowledge to oversee quality agreement management, support supplier qualifications, manage customer complaints, and drive thorough root cause identification for deviations, CAPAs, and validation lifecycle activities.
Additionally, this role provides critical QA oversight for analytical and microbiological laboratory operations, equipment/method validation, environmental monitoring compliance, and material shelf-life/expiry evaluations. Key Responsibilities Quality Systems, Investigations & CAPA Deviation Trending & Support: Provide quality assurance oversight for deviation investigations, process performance monitoring, and root-cause analysis.
Perform routine deviation trending to identify systemic patterns and drive proactive site improvement initiatives. CAPA Management: Apply robust knowledge of quality systems to ensure the definition and execution of highly effective Corrective and Preventive Actions (CAPA). Customer Complaint Management: Coordinate, track, and support the investigation of customer complaints. Collaborate with cross-functional technical teams to perform thorough impact assessments, establish root causes, and draft technical complaint investigation reports in a timely manner.
Annual Reviews: Coordinate and prepare Annual Product, Process, and System Reviews to verify ongoing validation status and regulatory compliance. Analytical & Microbiological QA Support Analytical Support & Change Control: Act as the primary QA compliance partner for site analytical and microbiological laboratories. Review, technically assess, and approve laboratory change controls, including updates to testing specifications, laboratory instrumentation, software parameters, and reagents.
Method Validation & Approval: Review, assess, and approve analytical and microbiological method validation, verification, co-validation, and transfer protocols and reports (e.g., for HPLC, GC, wet chemistry, physical testing, and microbiological assays) to ensure compliance with global regulatory filings, USP/EP/JP compendial requirements, and ICH Q2 guidelines. Environmental Monitoring (EM) & Micro Oversight: Provide Quality Assurance oversight for the site’s Environmental Monitoring, microbiological control.
Review EM data trends, support the investigation of cleanroom environmental or utility out-of-limit/out-of-trend (OOT) events, and participate in aseptic qualification activities, media fills, and contamination control assessments. Material Expiry & Retest Evaluation: Evaluate raw material, intermediate, and API stability data to support material expiry extension or retest date recalculation requests.
Ensure all material expiry evaluations are scientifically justified, fully documented, and compliant with site regulatory files. Agreements & Supplier Qualification Agreement Management: Act as the dedicated site coordinator for Quality Agreements (QAs) and Change Agreements (CAs). Oversight & Maintenance: Maintain and oversee the site’s QA and CA registers, execute periodic reviews of active agreements, and author or revise agreements as regulatory or business needs dictate.
Supplier Qualification Support: Support the site’s Supplier Qualification program. Help manage the app