Senior Qa Specialist Job In Dublin

Senior QA Specialist

PE Global is recruiting for a Senior QA Specialist on behalf of a leading pharmaceutical company based in Dublin North. This is a 12-month contract role.

Key Responsibilities:

• Support key stakeholders during the preparation and management of audits/inspections.
• Develop and communicate audit schedules and plans.
• Lead the creation of audit agendas, identifying risks and engaging with stakeholders.
• Review and approve audit reports and issue them.
• Input data and feedback into the Quality Management system and tools.
• Lead the review of audit actions from receipt to closure.
• Support quality system metrics review and reporting.
• Support the team during audits and inspections, taking on activities to support inspection/audit readiness.
• Lead audit consultancy communications in the management of the audit program.
• Partner with key stakeholders to collect feedback and enable the audit function to operate effectively.
• Act as a quality point of contact for audit/inspection queries from stakeholders.
• Participate and lead continuous compliance improvement projects within the team.
• Deliver Quality Assurance review and approval of SOPs and procedural documentation.
• Act as SME/Quality contact on key Quality system records, including audits, inspections, deviations, change controls.

Requirements:

• Minimum of 5 years experience in a GxP Quality Assurance or Compliance Management related role, with Quality Management Systems knowledge.
• Clear understanding of the audit lifecycle, from planning, conduct to closure.
• Demonstrable communication and project management skills; experience working in cross-functional teams.
• Strong Business Partner with a focus on collaboration and delivering results.
• Knowledge of applicable international GXP regulations and standards (e.g., GMP, GDP etc.).
• Excellent interpersonal skills, with the ability to communicate well, both verbally and written.
• Experience with Quality Systems/tools (e.g., Microsoft office, ECMS, EQV, Smart Sheet) an advantage.