Job Description
Summary: A Quality Audit Specialist is required for a biopharmaceutical company in West Dublin. The incumbent will be responsible for supporting audit and inspection function. The successful candidate will support the end to end process for audits and inspections, including preparation, conduct and supporting the response commitment process to closure. Responsibilities: Support key stakeholders during the preparation and management of audits/inspections. Support the development of the schedule / plan and its communication. Lead the creation of audit agendas by adequate identification of risks/issues and engagement with stakeholders to develop the audit. Review and approval of audit reports and issuance. Input data/feedback from report/response entry 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, by taking on activities to support inspection/audit readiness. Lead audit consultancy communications in the management of the audit program. Ability to work independently and within a team as an individual contributor. Partner with key stakeholders in the collection of key feedback to enable the audit function to operate effectively. Acts 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. Support audit conduct, when required. Qualifications & Experience: Bachelor's Science Degree. 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. Strong Business Partner with a focus on collaboration and delivering results. 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. Skills: inspection Quality Assurance Pharmaceutical Manufacturing