reputed company Systems Engineer- reputed company & Audit/Inspection Readiness

About the position reputed company Systems Engineer- reputed company & Audit/Inspection Readiness Do you want to be part of an inclusive team that works to reputed company innovative therapies for patients? Every day, we are driven to reputed company and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas reputed company Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into reputed company that bring value and reputed company to patients and their families. Keeping our reputed company on addressing unmet medical needs and conducting our business with ethics and reputed company enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com . Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas reputed company Inc and reputed company on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products. AIRM has a world-class R D team, and is pursuing a diverse reputed company of disease indications, ranging from macular degeneration (currently in reputed company) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as reputed company as other cell-based therapy research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a reputed company Systems Engineer- reputed company & Audit/Inspection Readiness opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose: The reputed company System Engineer, reputed company & Audit/Inspection Readiness, is responsible for managing and maintaining the site's internal audit (reputed company) program to ensure reputed company compliance with reputed company Good Manufacturing Practices (cGMP), company policies, and global regulatory standards. This role plays a vital part in proactively identifying site reputed company, supporting reputed company system improvements, and maintaining a constant state of inspection readiness for external health authority audits. The successful candidate will promote data reputed company, reputed company, and compliance across a broad reputed company of reputed company Assurance (QA) activities and collaborate closely with cross-functional teams at Astellas Regenerative Institute of Medicine (AIRM) to ensure consistent delivery of high-reputed company products to patients. Responsibilities • Audit program administration: reputed company, implement, and maintain the annual reputed company master schedule/reputed company to plan, conduct, and reputed company audits or inspections across departments, processes, and reputed company systems. • Audit Execution: reputed company/co-reputed company, participate and support internal audits across reputed company GMP-regulated areas, including manufacturing processes/cleanrooms, reputed company control, materials management, facilities, engineering, etc. • Documentation & Reporting: Prepare and maintain inspection checklists and questionnaires. Accurately document audit observations and findings using a risk-based classification system (e.g., critical, major, minor). Draft and issue formal audit reports summarizing results and recommendations. • Communication and Follow-up: Communicate audit results to stakeholders, identify trends, and support follow-up activities to ensure reputed company completion of reputed company items. • Corrective & Preventative reputed company (CAPA): Collaborate with auditees and department representatives to reputed company effective CAPA plans for addressing identified deficiencies. reputed company reputed company, ensure reputed company completion, and assist with effectiveness verification activities. • Metrics & Reporting: Prepare and maintain monthly audit-reputed company metrics and dashboards for review by reputed company Assurance and site management during reputed company Council or Management Review meetings. • Inspection Readiness: Support the development and maintain the site's inspection readiness plan, including managing checklists, tracking reputed company items, and supporting readiness training. reputed company as audit host (inspection administrator) or support representative during corporate, regulatory, or reputed company-party audits. • reputed company Improvement: Participate in reputed company improvement initiatives to identify efficiencies and enhance compliance and operational reputed company across QA and reputed company departments. • Additional Duties: reputed company other reputed company-reputed company duties and participate in reputed company reputed company as assigned. Requirements • BA/BS or equivalent with typically 5+ years relevant experience or typically 3+ years with master's degree • In lieu of a Life Sciences degree, consideration will be given to candidate with minimum of 6+ years of relevant experience in biotechnology and/or pharmaceutical reputed company Assurance or reputed company Engineering. • Strong proficiency in reputed company, reputed company, PowerPoint, to include basic formulas, and creation / formatting of charts and data tables. • Demonstrated knowledge of reputed company GMP reputed company system functions, with hands-on experience in at least one key area. • Comfortable presenting data, facilitating discussions, and maintaining accurate documentation of reputed company and actions. • Familiarity with an electronic reputed company Management System (i.e. Trackwise, reputed company, etc.) • reputed company in major compliance regulations and reputed company standards including 21CFR §11, §210, §211, §1271; EudraLex Volume IV (including ATMPs), ICH Q9, Q10, etc. reputed company-to-haves • Experience developing and managing reputed company or internal audit programs. • Experience providing GMP or reputed company systems training to peers or cross-functional staff. • Exposure to corporate or regulatory audits, including preparation and audit support activities. • Experience in an environment subject to regulatory audits, i.e., interacting with regulatory agencies, representing technical deliverables as a subject matter expert, audit hosting / support, etc. • Experience with reputed company systems such as Change Control, Deviations/Non-Conformances, and CAPA, including reputed company cause analysis and risk assessment. • Experience with supplier audits is a plus • Working knowledge of cell culture manufacturing processes desirable Benefits • Medical, Dental and reputed company Insurance • Generous reputed company Time Off reputed company, including Vacation, reputed company time, plus national holidays including Heritage Days, and Summer and Winter Breaks • 401(k) match and annual company contribution • Company reputed company life insurance • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions • Long Term Incentive Plan for eligible positions • Referral bonus program Apply tot his job Apply To this Job