Quality Investigation Lead

Quality Investigation Lead is required by Career Wise Recruitment for a 12-month contract position with our Waterford based pharmaceutical client. You would have to be 3 days working on site and 2 days working from home . You will have to be subject matter expert (SME) for site-wide Corrective and Preventive Action (CAPA) management and root cause analysis (RCA). This role is responsible for driving thorough, objective, and timely investigations into major quality deviations, out-of-specification (OOS) results, market complaints, and audit findings.

• Lead cross-functional teams in investigating major deviations and non-conformances, and
• Write concise, scientifically sound, and audit-ready investigation reports that withstand internal and external regulatory scrutiny (FDA, EMA, MHRA).
• Partner with Manufacturing, QC, QA, Validation, Engineering, and Supply Chain to gather data, evaluate impact, and determine precise root causes.
• Facilitate the creation of targeted, risk-proportionate CAPA plans that address underlying root causes rather than symptoms.
• Design and monitor CAPA effectiveness verification protocols to evaluate long-term risk mitigation and prevent recurrence.
• Act as a front-room or back-room SME during regulatory inspections (FDA, EMA) and customer audits for CAPA and deviation files.
• Monitor and report Key Performance Indicators (KPIs) related to CAPA health, investigation cycle times, and repeat deviation rates to senior management.
• Train and mentor site personnel on quality investigation techniques, evidence collection, and technical writing standard operating procedures (SOPs)

• Bachelor's degree in Chemistry, Biology, Chemical Engineering, Pharmacy, or a related scientific/technical discipline. 5+ years of experience in a cGMP-regulated pharmaceutical or biotechnology manufacturing environment.
• 3+ years of direct experience leading quality investigations and managing CAPA systems.
• In-depth expertise in FDA cGMP regulations (21 CFR Parts 210, 211, 820), EU GMP Annex 16
• Strong proficiency with electronic Quality Management Systems (eQMS) Veeva Vault