Co_ Kerry QA Systems Specialist

Job description

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com . Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact. Working Environment and Location This position is Hybrid from the Killorglin, County Kerry facility. Working Hours This position is a permanent, full-time position. Purpose and Scope Responsible for supporting the on-going development, implementation and maintenance of cGxP compliance. Role and Responsibilities Working in Systems: eQMS QA review & approval of eQMS records. Ensure that eQMS records are appropriately investigated and progressed in accordance with eQMS procedures. Support on-time eQMS progression working with all stakeholders. Issuance of TrackWise metrics monthly and trending on an on-going basis to support QMS management. Vault Quality Performs QA review and approval of, change requests and proposed revised/new standard operating procedures, test methods etc. to ensure that they are accurate, complete and compliant with the process and cGxP. Customer Complaints/Product Security Incidents & Recalls Ensures that customer complaints are investigated in an efficient and effective manner. Co-ordinates site wide investigations into complaints, prepares final report. Conducts investigations into any potential security incident and liaise with relevant personnel in the Astellas network. Conducts periodic evaluation of the recall procedure. Internal Audits Ensures efficient and effective cGxP auditing of AICL (KP)’s quality system. Prepares for an audit by performing a thorough review of cGxP regulations, GMP trends, guidance documents etc. Conducts the audit by reviewing the process, documentation and procedures. Reports the audit findings to Management. Follows up on audits to ensure that appropriate corrective actions have been implemented where necessary. Continue:Role and Responsibilities External Audits Prepares, conducts, reports and follows up on audits of key vendors and contract analysis agents to AICL in order to assess their compliance with quality/ technical agreements and cGMP. Assists in the preparation and overall support for external audits of AICL (including regulatory, corporate and customer audits). Regulatory updates and GMP Trends Review changes in Regulatory Updates and GMP trends as assess AICL (KP) compliance. Product Quality Reviews Coordinate report preparation and approval for Product Quality Reviews. Support related eQMS workflow progressions. Additional Tasks Working in Systems: LEAN Initiatives Lead or participate in lean and continuous improvement initiatives as required. Project Work Quality representative on major projects within AICL (KP). Ensures compliance with cGMP and regulatory submissions. Essential Qualifications BSc or equivalent academic qualifications. Preferred Qualifications Industrial/pharmaceutical experience would be an advantage. cGMP, Auditing, Customer Complaint Investigations, eQMS records support and related workflows, Safety, Good Documentation Practices, 5S. Benefits Careers | Astellas Why Astellas Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day. Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare. A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions. Our Organisational Values and Behaviours Integrity Innovation Impact One Astellas Accountability Courage Sense of Urgency Outcome Focus Skills and Capabilities Organizational Focus . We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help. #LI-Killorglin #LI-Hybrid #LI-ND1 Apply now » Apply Now Start applying with LinkedIn Please wait... Find similar jobs: