QA Specialist

Position Overview

· Position Title: Contract Quality Specialist - Quality Systems Centre of Excellence (CoE)

· Employment Type: Contract (Temporary)

· Location: Ballydine, Ireland

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

1. 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.

2. 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.

3. 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 approved vendor register, evaluate supplier assessment questionnaires, draft supplier quality agreements, and coordinate risk assessments for new or modified materials and service providers.

4. SAP Master Data & Governance

· Data Stewardship: Support SAP Master Data creation, standard updates, and strict data governance activities to maintain operational compliance and system integrity.

· Inventory Status & Expiry Control: Partner with warehouse and supply chain teams to govern material status changes, expiry date updates, and quarantine locks within SAP following material expiry evaluations.

5. Validation, Equipment & GMP Compliance

· 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.

· Submission Support: Support regulatory submissions, market renewals, and GMP declarations by compiling, reviewing, and providing timely and accurate Quality Assurance inputs.

· Validation Guidance: Provide QA guidance on compliance requirements to maintain validated status across systems and processes, including active participation in product and process risk assessments.

6. Audits, Walkdowns & Metrics

· Lead/Support Audits: Act as a lead or team auditor for internal GMP walkdowns and scheduled site audits to maintain inspection readiness.

· Metrics & Reporting: Support the development, compilation, and critical analysis of key site quality metrics. Draft compliance summaries and prepare reporting materials for site Quality Councils and cross-functional leadership teams.

Qualifications & Skills

Education

· Degree or postgraduate qualification in Chemistry, Microbiology, Biology, Science, Pharmacy, Engineering, or a related technical discipline.

Experience & Technical Knowledge

· Industry Experience: years of Quality Assurance, Quality Systems, or Laboratory QC/Microbiology experience in a highly regulated GxP pharmaceutical or biopharmaceutical manufacturing environment.

· Laboratory & Microbiology Compliance: Direct experience reviewing analytical/microbiological laboratory investigations (OOS/OOT), laboratory change controls, stability protocols, environmental monitoring data, or sterility assurance parameters.

· Method Validation Expertise: Demonstrated, practical knowledge of method validation, verification, and transfer principles (e.g., executing or reviewing protocols in line with ICH validation parameters).

· Environmental Monitoring: Practical knowledge of, microbiological testing methodologies (e.g., bioburden, endotoxin, growth promotion), environmental monitoring programs.

· Equipment & Validation Knowledge: Practical exposure to reviewing equipment qualification protocols, change controls, or engineering validation packages (ideally utilizing systems like Kneat and ProCal).

· Core QA Competencies: Proven understanding of Quality Agreements, Change Agreements, Supplier Qualification practices, Customer Complaint handling, and SAP Master Data governance.

Core Competencies

· Communication: Demonstrates excellent written and verbal communication skills; possesses the ability to convey complex quality, microbiological, and technical validation concepts clearly, accurately, and appropriately across diverse operational, laboratory, and leadership audiences.

· Teamwork & Collaboration: Collaborates effectively within cross-functional teams to support Right-First-Time (RFT) performance across site operations; willingly shares knowledge and resources to support mutual goals.

· Decision Making: Exercises sound, compliance-driven judgment utilizing data-driven insights; makes well-informed decisions that balance compliance standards with operational requirements.