Chinnu John

Quality Assurance Officer @Onyx Scientific

Sunderland, GB

Clinical/Regulatory Documentation & Registry-Relevant Activities•Supporting early-phase clinical trial material manufacturing and analytical testing, ensuring document accuracy, regulatory compliance, and inspection readiness.•Manage regulated documents including SOPs, PQRs, audit reports, safety documentation, and regulatory submission packages, supporting global disclosure and compliance requirements.•Ensure accuracy and consistency of source data used for regulatory submissions and safety reporting.• Coordinate documentation routing, approvals, and timely delivery to cross-functional, external, and global partners.•Maintain documentation, tracking logs, and dashboards, ensuring audit-ready records.Compliance, QMS & Data Integrity•Oversee QMS activities aligned with MHRA/FDA standards, including CAPA, deviations, and change controls, ensuring timely and compliant closure.•Conducting risk assessments and compliance reviews, identifying areas for improvement, and recommending solutions to mitigate compliance risks.•Conduct internal audits, prepare audit responses, and ensure inspection readiness for regulatory bodies.•Lead KPI and Quality Review Meetings, ensuring alignment with global processes and timelines.Cross-functional & Vendor Collaboration•Interact regularly with clinical, regulatory, QA/QC, and manufacturing teams to resolve documentation issues and ensure timely project execution.•Manage vendor qualification processes and oversee technical agreements and supporting documentation.Pharmacovigilance Support•Oversee AE/ADR reporting workflows, ICSR review, and safety documentation, ensuring rapid submission within mandated timelines.Key Achievements• Improved QMS efficiency by tracking the timelines. • Developed regulatory strategies with zero non-compliance during inspections.• Management of clinical and safety data.• Actively participated in self-inspections and facilitated training sessions, enhancing compliance awareness across teams.