Rose Castro

Background

About Rose Castro

GCP Compliance & Quality Professional with 12+ years of experience across regulated pharmaceutical and biotechnology environments. Proven leader in inspection readiness, GCP auditing, TMF quality oversight, and quality management system (QMS) implementation. Experienced working with sponsors, CROs, and global teams to ensure regulatory compliance, process optimization, and audit success. Adept at embedding inspection-readiness strategies into daily operations and championing continuous improvement through strategic problem-solving and cross-functional collaboration. Quick learner and able to multi-task adapting to changing priorities. Highly organized and self-motivated. Passionate to learn, train and mentor colleagues. Bilingual with excellent interpersonal skills.Key Skills:• Global Regulatory Standards GxP - FDA, EMA, ICH • SOPs, protocols, and controlled documents – creation, review and implementation • QC (document review) for NDA/ANDA submissions • Deviation and CAPA Management• Cross-Functional Team Training• Advanced proficiency in MS Office • Laboratory experience, in particular with HPLC, GC, MS, ELISA• Small Molecule Method Validation and Qualification• Analytical Method Lifecycle Management (Approval, Verification, Transfer)