Quality assurance

Quality & Compliance OversightEstablish and maintain QMS and ISMS in compliance with ISO standards and regulatory requirements.Prepare, review, and update SOPs to reflect changes in regulations, business needs, and process improvements.Ensure SOP compliance across departments through training, monitoring, and periodic reviews.Review risk assessments and implement effective risk mitigation strategies.Oversee computer system validation (CSV) activities and review software validation documentation to ensure GxP compliance.Audit, Inspection, Deviation & CAPA ManagementSupport and manage internal, project, and vendor audit programs.Support sponsor audits and regulatory inspections, including documentation handling and follow-up activities.Track and report audit findings, CAPA metrics, and quality indicators to senior management.Support the identification, documentation, and investigation of quality deviations.Clinical Data OversightCollaborate closely with CDM, CDISC, and Biostatistics teams to ensure data integrity and regulatory compliance.Support data review activities, including SDV, PK and statistical analysis, SDTM and ADaM Datasets, TLFs, SAP, Mockshells.Regulatory & Client EngagementLiaise with sponsors, clients, and regulatory authorities as needed.Support regulatory reporting activities and ensure proper documentation for internal teams and clients.Track and document cases involving scientific misconduct, serious breaches, and risk events.Management Review & Continuous ImprovementAnalyse audit results, process performance, nonconformities, and opportunities for improvement.Provide regular reports on key quality indicators and support strategic decision-making.Conduct training sessions to promote a culture of quality and compliance across teams.Training & Continuous ImprovementConduct training sessions for staff on QMS, ISMS, applicable standards, and regulations.Identify process improvement opportunities and support operational teams in issue resolution.Qualifications & SkillsBachelor’s or Master’s degree in Life Sciences, Quality Management, or related field.Minimum 1+ years of experience in quality assurance within clinical research.Strong knowledge of ISO 9001, ISO 27001, ICH-GCP, CDISC standards, and clinical data workflows.Proven experience in deviation management, audit hosting, and QMS implementation.Excellent communication, and analytical skills.Proficiency in quality tracking systems and documentation tools.Skills: clinical data,qms,documentation,iso,capa,compliance