Sindhu Smiley

Quality Assurance Specialist with 8+ years of experience in healthcare, life sciences, and patient support operations, specializing in Quality Management Systems (QMS), compliance, quality audits, SOP development, CAPA, process improvement, documentation control, and operational excellence. Experienced in conducting quality reviews, internal audits, root cause analysis, risk assessments, compliance monitoring, and implementing continuous improvement initiatives to ensure adherence to regulatory requirements and organizational quality standards. Strong expertise in quality metrics, performance monitoring, training, workflow governance, quality scorecards, stakeholder management, and cross-functional collaboration.

Proven ability to improve operational efficiency, strengthen quality systems, and support inspection readiness across healthcare operations.

Manager – Drug Safety associate & training specialist at Zyla Health (2025-03 – Present)

• Managed end-to-end quality assurance activities across healthcare operations while ensuring compliance with internal quality standards and regulatory requirements.
• Conducted 100% quality reviews of operational records, documentation, and case files to ensure accuracy, completeness, and compliance.
• Led internal quality audits and compliance assessments to identify process gaps and recommend corrective actions.
• Performed root cause analysis and implemented CAPA to improve quality performance and reduce recurring issues.
• Developed, reviewed, and maintained SOPs, Work Instructions, quality manuals, and controlled documentation.
• Created quality dashboards, KPI reports, and trend analyses for management review.
• Delivered training programs on quality standards, SOP compliance, and operational excellence.
• Collaborated with cross-functional teams to drive continuous process improvement initiatives.
• Developed and maintained pharmacovigilance SOPs, training materials, and quality documentation while supporting continuous process improvement initiatives.

Drug Safety & Quality Assurance at IQVIA Healthcare (2024-01 – 2025-03)

• Led the design, implementation, governance, and monitoring of quality management processes across patient support and healthcare programs to ensure alignment with organizational objectives, regulatory expectations, and patient safety requirements.
• Directed quality assurance frameworks supporting multiple patient support initiatives while establishing quality metrics, performance indicators, compliance scorecards, and monitoring systems that enhanced program effectiveness and operational consistency.
• Conducted detailed quality audits, compliance reviews, risk assessments, and operational evaluations to identify process gaps, strengthen governance controls, and support regulatory compliance requirements.
• Developed, reviewed, implemented, and maintained SOPs, quality manuals, procedural documents, workflow standards, and training materials supporting quality management systems and operational excellence.

Quality Analyst at Indegene Life Systems Pvt. Ltd. (2021-01 – 2023-10)

• Monitored and evaluated patient support program performance through structured quality monitoring frameworks, compliance reviews, operational assessments, and quality scorecards to ensure adherence to regulatory standards and organizational expectations.
• Conducted periodic audits of operational processes, documentation systems, patient interactions, and workflow activities to evaluate compliance with SOPs, quality requirements, and program governance frameworks.
• Performed adverse event reconciliation activities, source document verification reviews, safety data assessments, and quality checks to improve pharmacovigilance data accuracy and reporting quality.
• Developed and implemented CAPA initiatives addressing compliance observations, process deficiencies, and operational risks while improving overall quality management effectiveness.

Senior Executive – Business Process at Medi Assist Healthcare (2017-01 – 2018-04)

• Analysed healthcare claims data and identified utilization patterns, enabling process optimization and cost management initiatives. Collaborated with healthcare providers and hospitals to strengthen compliance monitoring systems and reporting frameworks.
• Developed analytical reports and management dashboards supporting strategic decision-making and operational improvements.

Medical Engagement Associate at Indegene Life Systems Pvt. Ltd. (2015-09 – 2016-12)

• Built and maintained professional relationships with healthcare professionals to communicate scientific information and support medical engagement initiatives.
• Coordinated medical education programs, webinars, workshops, and advisory board activities while ensuring regulatory compliance. Supported clinical trial monitoring, documentation management, data collection, and reporting activities in compliance with study requirements.

Bachelor of Science in Pharmaceutical Sciences – Jawaharlal Nehru University, Anantapur (2015)