Quality Investigation Lead is required by CareerWise 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.

THE ROLE

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)

REQUIREMENTS

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

Robust proficiency with electronic Quality Management Systems (eQMS) Veeva Vault

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📌 Quality Investigation Lead (Ontario)
🏢 CareerWise Recruitment
📍 Ontario