• Cork

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.

Interested candidates should send their CV to Audrey.mccarthy@qaresources.com

To apply for this job email your details to audrey.mccarthy@qaresources.com.