QA Resources have an opportunity for Quality Audit & Inspection Readiness (GxP)role to be based on client site in East Cork:
12 month initial contract, hybrid option
To lead and deliver a risk-based internal audit programme and a site-wide inspection readiness strategy, ensuring sustained compliance with global GxP requirements and successful regulatory inspection outcomes.
Key Responsibilities
Audit Leadership
Develop and execute a risk-based internal audit plan (typically 7–10 audits per annum minimum).
Lead and oversee high-risk audits including, but not limited to, data integrity, aseptic processing, and validation.
Ensure audit findings are robust, risk-based, inspection-ready, and aligned with regulatory expectations.
Inspection Readiness Programme
Own and lead the site inspection readiness strategy.
Plan, conduct, and oversee mock inspections aligned to global regulatory authorities, including the FDA and EMA.
Act as a key advisor and quality representative during regulatory inspections.
SME Coaching & Capability Building
Design and deliver inspection readiness and GMP capability training.
Coach Subject Matter Experts (SMEs) on inspection behaviour, response delivery, and documentation presentation.
Regulatory Response Oversight
Review and approve audit responses, CAPA plans, and regulatory responses.
Ensure all responses are root cause-driven, scientifically sound, and regulatorily robust.
Data-Driven Risk Management
Oversee analytics-driven audit planning activities.
Review and trend site quality metrics including deviations, CAPA, OOS, and OOT data.
Identify emerging compliance risks and areas requiring proactive intervention.
Process Design and implementation Management
Accountable for the design, standardisation, and deployment of internal audit and inspection readiness processes.
Translates regulatory requirements into clear, scalable, and sustainable site processes.
Leads process effectiveness reviews, ensuring:
Clear ownership and governance
Defined interfaces with Quality Systems (CAPA, Deviations, Change Control)
Embedded risk based decision making
Drives process maturity from reactive compliance to proactive, predictive assurance.
Qualifications & Experience
Degree in Science, Pharmacy, Engineering, or a related discipline.
8–12+ years' experience in pharmaceutical manufacturing, QA, or compliance roles.
Extensive experience leading and supporting regulatory inspections.
Strong expertise in GMP, validation, and data integrity requirements.
Lean Six Sigma Black Belt qualified
Key Skills & Competencies
Strategic leadership and decision-making.
Advanced regulatory and technical writing capability.
Ability to influence and engage senior stakeholders.
Coaching, mentoring, and facilitation skills.
Strong risk-based and data-driven mindset.
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