and executing IQ, OQ, and PQ documentation. Strong technical writing and documentation skills. Experience working under FDA, EMA...
expertise in regulatory and compliance requirements for microbiological methods and specifications, including ICH, FDA/EMA...
expertise in regulatory and compliance requirements for microbiological methods and specifications, including ICH, FDA/EMA...
Experience in reviewing and negotiating relevant agreements Familiarity with GCP, ICH, and relevant FDA/EMA guidelines...
to internal and external audits, including Health Authority inspections (FDA/EMA), and support the execution of corrective action...
Authority inspections (FDA/EMA), and support the execution of corrective action plans. Apply risk management processes...
assessment (EMA) and smartphone-based platforms Development and pilot testing of Just-in-Time Adaptive Interventions (JITAIs... Coordinate participant onboarding to smartphone-based EMA and digital monitoring platforms;troubleshoot technical issues...
Experience working in global, multi-site life sciences organisations Supporting regulatory inspections (e.g., FDA, EMA...
and ensure aligned analyses and documentation. Stay current on global regulatory requirements (FDA, EMA, ICH, GCP). May...
inspections (e.g., FDA, EMA) Familiarity with serialization, batch traceability, and supplier qualification processes Experience...