Quality Systems Specialist

Quality Systems Specialist
Days & hybrid
RK26417
Contract 11 months
Tipperary



We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Tipperary . This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



This role is responsible for supporting day-to-day Quality Assurance activities at the 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.





Key Responsibilities:

• 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 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.
• Supplier Qualification Support: Support the site's Supplier Qualification program. Help manage the approved vendor register, evaluate supplier assessment questionnaires, draft supplier quality agreements, and coordinate risk assessments for new or modified materials and service providers.
• Data Stewardship: Support SAP Master Data creation, standard updates, and strict data governance activities to maintain operational compliance and system integrity.
• Equipment Validation Oversight: Provide Quality Assurance oversight, review, and approval for equipment, utility, and facility qualification/validation activities. Evaluate and approve IQ/OQ/PQ protocols, validation execution data, and final reports (utilizing electronic validation systems such as Kneat and ProCal) to ensure compliance with cGMP and data integrity principles.
• Lead/Support Audits: Act as a lead or team auditor for internal GMP walkdowns and scheduled site audits to maintain inspection readiness.

• Degree or postgraduate qualification in Chemistry, Microbiology, Biology, Science, Pharmacy, Engineering, or a related technical discipline.
• 3+ years of Quality Assurance, Quality Systems, or Laboratory QC/Microbiology experience in a highly regulated GxP pharmaceutical or biopharmaceutical manufacturing environment.
• Direct experience reviewing analytical/microbiological laboratory investigations (OOS/OOT), laboratory change controls, stability protocols, environmental monitoring data, or sterility assurance parameters.
• Demonstrated, practical knowledge of method validation, verification, and transfer principles (e.g., executing or reviewing protocols in line with ICH validation parameters).
• Practical exposure to reviewing equipment qualification protocols, change controls, or engineering validation packages (ideally utilizing systems like Kneat and ProCal).