Our client, a leading global healthcare company based in Cavan, is hiring for a QA Senior Specialist Audit Readiness - Europe.
Responsibilities:
Reporting to the QA Manager Strategic Readiness, supports regional program for inspections/audit readiness. Establishes and maintain divisional procedural requirements for external audit support and processing.
Utilizes ANQA strategic direction and data to develop audit readiness strategies, communication plan etc. per site as audit preparation. With sites, prepare audit preparation plans and assist in execution of the plans.
Work with the sites and other functional groups to determine best in class replication opportunities within the Quality systems. Partner with the sites through assessments and simulations to determine and mitigate areas of high risks.
Assists the sites, in coordination with quality system owners, in remediating and establishing action plans on critical and major audit findings.
Education & Experience:
Education: Bachelor’s degree in applied, physical, or life science, engineering or business. Master’s degree preferred.
A minimum of 5 years of experience in Quality, Research and Development (R&D), Supply Chain and Manufacturing, regulatory and quality audits/inspections, or related experience is required. Experience working with sites, R&D, supplier, TPM, regulatory and affiliates is preferred.
Flexibility to travel, sometimes at short notice and to respond positively to dynamic situations.
For a confidential discussion and more information on the role, please contact Colin Byrne.
colin.byrne@collinsmcnicholas.ie
071-9140255