Senior Quality Assurance Specialist

24 hours ago


thane, India beBeeCompliance Full time

Quality Assurance ProfessionalThis is a pivotal role in ensuring quality excellence, maintaining inspection readiness, and enhancing our Quality Management System (QMS) across all programs.Execute internal, external, vendor, and investigator site audits to ensure compliance with regulatory standards.Elevate the QMS across global studies and vendors through continuous improvement.Act as SOP owner for QA and compliance documentation—authoring, revising, and harmonizing procedures across business units.Manage SOP lifecycle processes, including creation, periodic review, deviation tracking, version control, and global rollout.Support regulatory inspection readiness (FDA, MHRA, EMA, DCGI, etc.) and act as QA representative during inspections.Lead CAPA investigations, ensuring timely and effective root cause analysis, remediation, and verification of effectiveness.



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