Senior Quality Audit Specialist

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Team Horizon is seeking a Senior Quality Audit Specialist for an initial 12-month contract with a multinational Pharmaceutical company at their Dublin based manufacturing facility.

Why you should apply:

• Exciting opportunity to step into a pivotal role and be responsible for the oversight of the company supplier GMP/GDP/Med Device audit program, from audit planning, conduct, reporting, to audit closure, as well as audit CAPA approvals and close-out.


• Competetive salary / rates on offer

What you will be doing:

• 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.

What you need to apply:

• Minimum of 5 years’ experience in a GxP Quality Assurance or Compliance Management related role, with Quality Management Systems knowledge.


•  Clear ubderstanding 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 are required, as is the ability to communicate well, both verbally and written.


• Experience with Quality Systems/tools (e.g. Microsoft office, ECMS, EQV, SmartSheet) an advantage.