Quality Analyst

Job Title Quality Analyst Requisition JR000015736 Quality Analyst (Open) Location College Park, Dublin - IRL006 Additional Locations Job Description Summary Quality Assurance Specialist Job Description Batch Review Preparation of CMO documentation for batch review. Review of batch records, addressing discrepancies and escalating where required to management. Preparation of disposition and release certification for reviewed batch records. CMO Governance Management and oversight of third party supplier activities relating to the manufacture, packaging and testing of product. Regular telephone and email communication with CMOs to ensure timely manufacture and resolution of quality issues for product. Continuous monitoring of product and performance from CMOs. Quality Support and Deputation Monitoring cold-chain transportation, for both qualification and routine CMO Maintenance Input into Technical Quality Agreements Post-launch support for quality activities in various countries Management of delegated projects Audits Drive the audit readiness programme to ensure audit compliance at all times. Quality/QMS Projects As required. Minimum Requirements Education / Experience / Skills: Bachelor’s Degree in scientific discipline, preferred +3-5years’ experience working as QA Specialist Direct experience working with Quality Systems (deviations, change controls, training, supplier qualification and document management systems) Knowledge of cGMP requirements for pharmaceutical manufacturing and knowledge of GDP and ISO 13485 Competencies: Good interpersonal skills; ability to communicate well, both verbally and written Able to function effectively in teamwork environment Demonstrate ability to work independently Thorough, diligent and good attention to detail Collaborator with strong levels of engagement with individuals and team High level of delivery and work completion Strong organisational skills At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence. We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference. We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com. At Keenova, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop. Invest in your own career with Keenova and let’s do something dynamic together. Keenova provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law. Additional information on Keenova’s hiring practices may be found by clicking