Senior Quality Audit Specialist

3 weeks ago


Dublin, Ireland TEAM HORIZON Remote Work Freelance Full time
Description
·

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.



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