SummaryA Senior QA Specialist is required for a biopharmaceutical company based in Athlone. The incumbent will be responsible for delivery of quality assurance activities to ensure commercial and clinical products are manufactured in accordance with cGMP, Corporate and Regulatory requirements.ResponsibilitiesSite QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to site’s manufacturing and product supply.Acts as quality point person, providing guidance and feedback on quality assurance issues.Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk.Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Clinical and Commercial Operations groups.Provide advice on GxP within the site, with reference to guidelines and regulations.Support technology transfers and new product introductions.Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required.Provide quality oversight of Validation activities for the site.Support QP batch release activities to maintain release schedule.Actively support audit readiness activities and regulatory agency and internal audits.Actively contributes to continuous improvement activities.Lead coordination of referrals of regulatory documentation (e.g. dossiers, site impact assessment, annual reports, or QP declarations) and market-specific documentation for site accreditations and product reviews.Actively engage in process improvements and risk assessments, such as benchmarking internal and external quality assurance practices to identify innovative efficient and effective practices.Conduct data analysis and development of reports and insights on quality metrics and key performance indicators, using digital tools and processes.Support overall planning around quality training and guidance for internal / external stakeholders for area.Guide early-career team members around quality processes, related digital tools, and compliance requirements.Acts as delegate for QA management.Qualifications & ExperienceThird level qualification e.g. B.Sc. in science/pharmacy.A minimum of 7 years relevant experience within the pharma industry or a related field.Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required.Direct experience of New Product Introduction required.Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing.Experience with quality processes across multiple areas.Experience interpreting and guiding team members around principles and concepts of compliance management within a regulated environment.Experience troubleshooting issues across quality areas.Experience implementing newer digital tools and technologies related to QA reporting, documentation, and analysis.Good knowledge of relevant computer packages e.g. TrackWise or similar.High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required.
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