Quality Investigaton Lead

Quality Investigation Lead - 12 month contract at a Waterford based pharmaceutical client. 3 days on site, 2 days remote working.

Responsibilities

• Lead cross functional teams in the investigation of major quality deviations, out of specification (OOS) results, market complaints, and audit findings.
• Develop concise, scientifically sound, audit ready investigation reports that withstand scrutiny from regulatory bodies such as FDA, EMA, and 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 addressing underlying root causes rather than symptoms.
• Design and monitor CAPA effectiveness verification protocols to evaluate long term risk mitigation and prevent recurrence.
• Serve as a subject matter expert 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).

Qualifications

• 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 (21CFR Parts210,211,820) and EU GMP Annex16.
• Strong proficiency with electronic Quality Management Systems (eQMS) Veeva Vault.

Location & Contract

Waterford, Ireland - 12 month fixed term contract. Hybrid working arrangement (3 days on site, 2 days remote).