Proclinical have a unique chance for you to join one of the leading pharmaceutical companies in the world as a Senior Quality Assurance Associate in their Ireland office. This role is a chance to elevate the quality of the entire organisation.
Provide QA support and oversight to the Irish operations team ensuring compliance with EU, Irish and FDA GxP regulatory requirements QA review and approval of quality documentation generate in Irish operations e.g. including but not limited to Deviations, CAPAs, change controls and logbooks Support a "Quality on the floor" culture and facility walk rounds to maintain a high level of compliance and QA oversight by working closely together with operations Generate and prepare quality documents Support the preparation, execution and follow up on regulatory inspections. Perform (plan, execute, follow up) self-inspections in a timely manner as per plan Provide QA review for the eQMS system documents Aid in the management and proactively initiate and support continuous improvement of the Quality Management System. Deliver GxP compliance training to operational areas Ensure own KPI's, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines.
Skills and Requirements
Experience of working within a GMP Sterile manufacturing environment Good knowledge of controlled processes and GMP requirements to a QMS Proficient in Microsoft Office and experience in database use and eQMS systems Good organisational and time management skills and able to demonstrate flexibility and adaptability. Knowledge of GCP and GMP with regards to QMS activies Good team player and must also be able to work alone Experience in Competent authority, Regulatory body inspections and audits.
We hope to hear from you soon.