datasets. Prepare submission artifacts (reviewer's guides, Define.xml, annotated CRFs) aligned with FDA/EMA expectations... as an Applicant in the United States. Capgemini is a global business and technology transformation partner, helping organizations...
assessment, protocols (DQ, IQ, OQ, PQ) summary reports, and validation master plans/reports. As member of globalengineering... team, strongly connecting and involving in DP globalengineering projects planning and implementation. Regulatory...
with global regulatory submissions (e.g., IND/CTA, BLA/MAA) and interactions with major health authorities (FDA, EMA...At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare...
leadership for equipment and process introduction, technical transfer, engineering studies, and complex troubleshooting through..., Validation, Quality, and external partners to ensure processes are scalable, robust, and aligned with global regulatory...
of cleaning processes. Ensure compliance with regulatory guidelines (FDA, EMA, cGMP, ICH) and internal SOPs. Participate..., Engineering, and Validation teams. May interact with regulatory inspectors, third-party laboratories, consultants, and equipment...
more: . Position Summary The Quality Engineering team is responsible for quality oversight of engineering and validation lifecycle... validation, and technology transfer. The Senior Specialist, Quality Engineering is responsible for quality oversight. Duties...
of accountability and operational excellence across all assigned facilities. Job Description: Support the implementation of global... facilities. Your Profile Education and Experience: Bachelor’s degree in Life Sciences, Quality Management, Engineering...
to ensure compliance with global regulatory standards. The role involves managing validation lifecycle activities, coordinating... audits & inspections (FDA, EMA, MHRA) Manage change control, deviation, CAPA related to validated systems Mentor and guide...
goals and ensure high performance. Oversee daily aseptic manufacturing operations, ensuring compliance with FDA, EMA..., and other global regulatory requirements. Maintain strict adherence to cGMP, SOPs, and aseptic processing standards. Partner...
knowledge of PV regulations: FDA (21 CFR 312.32, 314.80, FAERS), EMA GVP (Modules VI, VII, IX), and ICH E2 (E2A-E2F). Direct... (Big 4 or life sciences consultancies) in PV projects. Involvement in regulatory inspections (FDA/EMA GVP), and audit...