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...
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...
/Reports, Risk assessments (potential to facilitate risk assessments)). Qualifications Minimum B.S. degree in Engineering..., computer system validation/computer software assurance, and data integrity programs. Knowledge of relevant FDA and 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...
, 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...