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...
and final drug product samples. We ensure adherence to Good Manufacturing Practices (GMP) and regulatory guidelines (FDA, EMA... or engineering field. Job Level: Internship Additional Information The base compensation range for this role...
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 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...
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...
successful interactions with the FDA, EMA, and other global health authorities. You don't just pass inspections;you build the organizational... of this team, you will collaborate closely with stakeholders across Clinical Facilities, Technical Development, and Global Quality...
, integrated architecture and engineering practice, we value the diversity of perspectives, experiences, abilities, and expertise... Excellence & Project Delivery Oversee design execution for complex biotech facilities, ensuring compliance with GMP, FDA, EMA...
Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck... in chromatography, filtration, and analytical techniques used in downstream processing. Ensure adherence to FDA, EMA, ICH guidelines...