Quality Investigaton Lead

A 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
• Strong proficiency with electronic Quality Management Systems (eQMS) Veeva Vault

Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.