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Barden are delighted to be supporting our Global Biopharmacuetical client in their search for Senior Quality Assurance Specialist (Audit) for their state of the art facility in Dublin.
ABOUT THE ROLE:
The Senior Quality Assurance Specialist (Audit) will be responsible for supporting the audit and inspection function. They will manage the end-to-end process for audits and inspections, including preparation, conduct and supporting the response commitment process to closure.
Key Responsibilities:
- Support key stakeholders during the preparation and management of audits/inspections.
- Support the development of the schedule / plan and its communication.
- Ensures the timely creation and performs the review of audit agendas by adequate identification of risks/issues and engagement with stakeholders to develop the audit.
- Ensures the timely issuance and performs review and approval of audit reports.
- Maintaining up to date data in the Quality Management system and tools.
- Ensures timely execution of confidentiality/non-disclosure agreements.
- Lead the review and approval of audit actions e.g. CAPAs 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 related activities.
- 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.
About the Person:
- 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.
- 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.
