Quality Assurance Specialist

Overview:Our client is a global specialty pharmaceutical company focused on developing and commercialising medicines for rare diseases and complex medical conditions, with a strong commitment to innovation and improving patient outcomes.Based in Dublin, we are looking to hire 2 Quality Assurance Specialists for their expanding team. The QA Specialist is responsible for support of the Manufacturing Operations department and maintenance of the QMS within the manufacturing facility. This position will have a wide range of tasks which include on the floor support, performance of investigations related to deviations, nonconformances, and out-of-specification/out-of-trend events. This role will require shift work.

Responsibilities

Monitor day to day operations to ensure procedures are followed, identify gaps, and escalate issues that may impact product quality or regulatory compliance.Review manufacturing or operational record for completeness and compliance before product release.Review and approve all raw materials, intermediates used in manufacturing.Perform and evaluate trending of the QMS to support management reviews, investigations, and continuous improvement initiatives.Interpret and properly apply all applicable regulatory requirementsLead and/or support investigations through cross functional team involvement.Present investigations and deliver disposition recommendations to site leadership and QP.Improve existing procedures or create new procedures to align with cGMP and regulatory requirements.Review and approve procedures, protocols, reports, etc., as required.Lead and/or assist with continuous improvement, compliance-based, and site projectsSupport lean manufacturing initiatives both at the site level and within the greater Quality/Operations organization.Participate in internal/external audits as an SME or member of the audit team.Provide shift support as and when required to ensure sufficient support the Manufacturing Operations Department.Approval of Change Proposals for GMP impacting changes on site at CPMF.

Requirements

Bachelor’s degree or higher in a scientific discipline, such as Biology, Chemistry or Engineering.Minimum of 2 years’ experience working in a current Good Manufacturing Practice (cGMP) environment.Strong communication, presentation and interpersonal skills, with the ability to coach and mentor colleagues effectively.Ability to adapt to change, demonstrate initiative and work independently while exercising sound judgement and decision-making.Working knowledge of statistical methods, with the ability to analyse, trend and interpret data to support decision-making and continuous improvement.If this QA Specialist job in Dublin is of interest to you apply now or contact David Smith at Collins McNicholas Recruitment to learn more.