Location:DundalkHours:37.5 hours per weekSalary:CompetitiveBusiness Unit: Pharma ServicesOpen To: Internal & External ApplicantsRef No.:HRJOB10977ㅤThe RoleThe Quality Assurance Specialist will play a crucial role in assessing and enhancing the Quality System to ensure Good Manufacturing Practice (GMP) compliance and the quality of pharmaceutical products. They will provide quality assurance support and advice to various operational departments, interacting with both internal and external customers to meet project timelines while maintaining high standards of product quality and compliance.Key responsibilities include assisting in the implementation and continuous improvement of quality systems such as deviation and CAPA management, change controls, and risk assessments. The post holder will also serve as a point of contact for queries related to product compliance and quality.Additionally, the post holder will be involved in monitoring and reviewing quality system elements, such as deviation reports, corrective and preventative actions, change controls, complaints, audits, and out-of-specification reports. They will review data related to secondary packaging activities and validation reports to ensure accuracy and compliance.ㅤKey RequirementsHave eligibility to work in IE OR possess a valid work permit that will allow you to take up full time employment in IEDegree (or equivalent) in a Life Science or closely related field OR Significant EU GMP experience working within the Pharmaceutical Industry in a Quality role along with demonstrable knowledge may be considered as sufficient to meet educational requirements for this role.Significant EU GMP experience working within an established Quality System (e.g. GMP, ISO)Comprehensive, working knowledge of the regulatory requirements for pharmaceutical products are essential, including familiarity with the principles of Good Manufacturing Practice, Pharmaceutical Quality Systems, Quality Risk Management and Pharmaceutical Product LifecyclesㅤㅤFurther InformationThe working pattern for this role is a flex pattern between the hours of 07:00 – 19:00 with core hours of 10:00 – 16:00.You will also be eligible for hybrid working following the successful completion of probation.This role requires coverage beyond normal working hours on a regular basis and it is a condition of your employment that you are able to fulfil this requirement of the role.ㅤApply NowApply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible.ㅤClosing DateWe will no longer be accepting applications after 5pm on01 October 2025.ㅤRECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CV's received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.