{"id":1743560,"url":"https://alion.io/job/astellas-quality-assurance-for-integrated-batch-release","title":"Quality Assurance for Integrated Batch Release","company":{"id":703794,"name":"Astellas","domain":"astellas.com","url":"https://alion.io/company/astellas-2","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Ireland"],"countries":["IE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":51000,"max_usd":109000,"period":"year","method":"role_country_seniority_unknown","sample_n":103},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-03T04:36:55Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-10-23T01:37:47Z","board_verified":true,"closed_at":null,"days_open":20,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":20},"description":"About Astellas\nAstellas 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.\nAre you driven to make a real difference in the lives of patients?\nWe'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.\nWorking Environment and Location\nThis position is 100% onsite in Tralee, Ireland.\nPurpose and Scope\nThe role is part of the Quality Assurance function within the Astellas Ireland Co. Ltd. Tralee Plant Aseptic Manufacturing Facility. The QA resource will provide quality oversight and support for the qualification and validation of integrated GxP systems required to enable a compliant digital batch release process and review-by-exception operating model. The role will ensure that system design, configuration, integration, testing, data flows and associated controls meet applicable GxP regulations and guidance, data integrity requirements, industry best practices, local regulations, and internal policies and procedures. Working closely with Validation, Engineering, Manufacturing, Facilities, Digital/IT, Document and Data Management, Quality Control (QC), and other GxP-supporting functions, the role will review and approve qualification strategies, protocols, evidence, deviations, risk assessments and reports, and verify that system-generated data and exception-based review processes are accurate, complete, reliable and suitable to support batch disposition and release.\nRole and Responsibilities\nProvide QA oversight and approval for the qualification and validation of integrated GxP systems, ensuring risk-based strategies, data integrity, GMP compliance, and readiness to support digital batch release and review-by-exception processes.\nPartner with Validation, Manufacturing, Laboratory, Quality, and system owners to define and approve requirements for digital batch release and review-by-exception, including CPP/CQA limits, exception and alarm management, audit trails, electronic records/signatures, data workflows, interfaces, traceability, access controls, segregation of duties, escalation, and contingency arrangements.\nProvide hands-on QA support to internal teams, suppliers, and contractors, ensuring compliance with GxP requirements, SOPs, validation expectations, and quality standards; support the development, review, and approval of GMP documentation, including specifications, protocols, reports, SOPs, deviations, CAPAs, and change controls.\nCollaborate with equipment owners, Validation, Engineering, and cross-functional stakeholders to ensure facility, equipment, software, and technical systems are appropriately qualified and validated, with effective quality requirements established from project initiation.\nSupport regulatory and customer audits, regulatory communications, and collaboration with other QA organisations, Astellas sites, and relevant industry groups, ensuring effective communication and continued commercial and regulatory readiness.\nProvide QA leadership and influence across the plant, fostering a strong quality culture, supporting staff development, and ensuring QA activities and priorities align with business needs and GMP requirements.\nEssential Qualifications\nScience based degree with experience in a cGMP compliance environment, experience of QA function in an aseptic manufacturing plant essential.\nQP Eligible preferably\nBenefits\nCareers | Astellas\nWhy Astellas\nGlobal collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. \nReal-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.\nRelentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.\nA 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.\nOur Organisational Values and Behaviours\nIntegrity\nInnovation\nImpact\nOne Astellas\nAccountability\nCourage\nSense of Urgency\nOutcome Focus\nSkills and Capabilities\nOrganizational Focus\n.\nWe are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.\nBeware 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.","description_format":"text","description_chars":5266,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"Ireland","iso":"IE","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-03T04:36:55Z"}],"visa":[],"liveness":{"score":50,"band":"ok","label":"Likely open","p_open":1,"p_active":0.665,"p_room":0.75,"age_days":19,"expected_fill_days":20,"reasons":["conf:2","velocity","win:late"],"computed_at":"2026-10-22T06:10:10Z"},"pay":null,"html_url":"https://alion.io/job/astellas-quality-assurance-for-integrated-batch-release","json_url":"https://alion.io/job/astellas-quality-assurance-for-integrated-batch-release.json","meta":{"generated_at":"2026-10-23T05:17:01Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":8707,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-24T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":703794},"rest":"https://alion.io/mcp/rest/get_company?id=703794"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fastellas-quality-assurance-for-integrated-batch-release"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fastellas-quality-assurance-for-integrated-batch-release"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fastellas-quality-assurance-for-integrated-batch-release"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/astellas-quality-assurance-for-integrated-batch-release\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fastellas-quality-assurance-for-integrated-batch-release"}]}