Senior Quality Audit Specialist

Summary:

12 month contract

Our Dublin based pharmaceutical client is looking for a Senior Quality Audit specialist to join their team on a 12 month contract

Requirements

• Support key stakeholders during the preparation and management of audits/inspections.
• Lead the creation of audit agendas by adequate identification of risks/issues and engagement with stakeholders to develop the audit.
• Input data/feedback from report/response entry into the Quality Management system and tools.
• Support quality system metrics review and reporting.
• Support the team during audits and inspections, by taking on activities to support inspection/audit readiness.
• Lead audit consultancy communications in the management of the audit program.

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.
• Knowledge of applicable international GXP regulations and standards (e.g., GMP, GDP etc.).
• Experience with Quality Systems/tools (e.g. Microsoft office, ECMS, EQV, SmartSheet) an advantage.

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