Senior Quality Assurance Specialist

The Quality Assurance, QP has responsibility for the management and maintenance of Quality Management System. Furthermore, the job holder is acting as qualified person as per EU GMP.Please note: This is a hybrid role with 3 days onsite required in City West, Dublin.Role:Manage the QMS, ensure the QMS is fit for purpose, making changes as necessary approving SOPs and Quality System documents.Maintain Quality processes.Participate in managing communications with and represent the company in front of HPRAProvide QA expertiseSupport HPRA inspections and prepare written responses to inspections.Prepare and approve HPRA variations.Provide QA oversight and expertise for New Product IntroductionsInitiate / approve Non-Conformances (NC), CAPA, change controls and complaints.Ensure annual review of supplier and customer bona fides to verify compliance with Guidelines on Good Distribution Practice.Ensure Batch record review to verify compliance with GMP and Market Authorization prior to batch release.To approve or reject finished products.Ensures that each finished medicinal product batch has been manufactured in accordance with GMP and the MAReview, and where appropriate, preparation and regular update of technical agreements with licensees and 3rd party contractors.Periodic review of QMS and operational procedures for regulatory compliance through internal audit system.Qualifications/ Education:BSc (Hons) in Science or equivalent.QP qualification.Thorough working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices.Minimum of 5 years of experience working in Quality Assurance in the Health Care Industry.Good communication skills