Quality Investigation Lead

Job Overview

We are seeking a Quality Investigation Lead for a 12-month contract with a pharmaceutical client in Waterford, Ireland. The role requires working three days onsite and two days remotely. The successful candidate will serve as the site-wide subject matter expert for Corrective and Preventive Action (CAPA) management and root cause analysis (RCA). This role involves leading thorough, objective, and timely investigations into major quality deviations, out-of-specification (OOS) results, market complaints, and audit findings.

Key Responsibilities

• Lead cross-functional teams to investigate major deviations and non-conformances.
• Compose concise, scientifically robust, and audit-ready investigation reports compliant with regulatory standards (FDA, EMA, MHRA).
• Collaborate with departments such as Manufacturing, Quality Control, Quality Assurance, Validation, Engineering, and Supply Chain to collect data, assess impacts, and ascertain accurate root causes.
• Develop targeted and risk-proportionate CAPA plans addressing root causes rather than symptoms.
• Design and oversee CAPA effectiveness verification protocols for long-term risk mitigation and prevention of recurrence.
• Serve as a front-room or back-room expert during regulatory inspections and customer audits concerning CAPA and deviation documentation.
• Track and communicate Key Performance Indicators (KPIs) related to CAPA system health, investigation durations, and repeated deviations to senior management.
• Provide training and mentorship to site staff on quality investigation methods, evidence collection, and technical writing SOPs.

Qualifications and Experience

• Bachelor’s degree in Chemistry, Biology, Chemical Engineering, Pharmacy, or a related scientific or technical field.
• Minimum 5 years' experience working within a cGMP-regulated pharmaceutical or biotechnology manufacturing environment.
• At least 3 years of direct experience leading quality investigations and CAPA system management.
• Comprehensive knowledge of FDA cGMP regulations (21 CFR Parts 210, 211, 820) and EU GMP Annex 16.
• Strong familiarity with electronic Quality Management Systems (eQMS), specifically Veeva Vault.

Additional Information

You may contact Louise Mulligan for further details at phone number 0949003979 or via email at lmulligan@careerwise.ie.

CareerWise Recruitment, established in 1999, specializes in placing management and technical professionals within life sciences, ICT, engineering, food, and agriculture sectors. By applying, candidates consent to the handling and storage of their data per CareerWise Recruitment’s privacy policy. The agency ensures candidates' CVs and personal data will not be shared with client companies without their prior consent and will respect any withdrawal or amendment of this consent.