Dr Sonali Solanki

• Assess the impact of any changes to worldwide regulations and/or processes on existing metrics and update as required in order to ensure continued suitability.
• Handling compliance to the regulatory guidelines including due diligence and compliance to local, national guidelines.
• Performing risk assessment and identifying high risk areas with meticulous planning and implementation of mitigation measures
• Review feedback from Health Authorities or other external parties and prepare responses and integrate the feedback to organization standards as appropriate
• Ensure compliance to good laboratory practices (GLP)
• Ensure implementation of quality management system to the entire network of labs across the country in the preanalytical, analytical and post analytical lab workflow.
• Manage assigned monitoring activities / metrics production and lead investigations in to any deficiencies identified, develop and implement corrective and preventative actions (CAPAs) and measuring their effectiveness
• Established a culture of continuous improvement, fostering innovation and driving sustainable growth across the organization
• Maintain medical laboratory equipment performance by establishing quality standards and ensuring the implementation of SOPs
• Document Control
• Implement new programs, tests, methods, instrumentation, and procedures including validation/ verification and apporvals
• Subject matter expert during audits and inspections including CAP, NABL, ISO; lead the preparation of responses to findings and the development and implementation of CAPAs
• Conduct Quality Audits for existing labs & partners conducting gap analysis activities including evaluation of clinical and medical processes
• Resolve customer queries and escalations/concerns

• Assessed competitive landscapes by conducting comprehensive market analyses, informing strategic planning efforts within the organization.
• · Conducted Clinical Marketing Education Programs, Seminars, Promotional Events and In-service Programs in the respective region in order to improve BD value proposition amongst both clinical and economic buyers, by engaging KOLs towards business outcome and achieve regional business objectives.
• Collaborated closely with marketing teams to develop evidence-based promotional materials that highlight product benefits and support sales efforts.
• Ensured timely dissemination of critical safety updates to healthcare providers through proactive communication efforts and targeted outreach campaigns.
• Served as a key liaison between internal stakeholders and external partners, fostering productive collaborations that advanced company goals.
• Established a robust system for tracking and reporting adverse events, strengthening patient safety measures across the organization.
• Played a pivotal role in product launches, working closely with commercial teams to ensure seamless integration of medical affairs activities into overall launch plans.
• ·Support / assist sales organization with product evaluations, clinical audits in hospitals/labs, setting protocols and processes in hospitals & clinics critical to business technical challenges (including but not limited to troubleshooting and product applications) in order to attain high levels of product penetration, query resolution and trouble free product application.
• Managed the review and approval process for medical communications materials, ensuring accuracy and alignment with company objectives.
• Enhanced medical education initiatives by creating engaging training materials for healthcare professionals on new products and therapies.
• Developed and maintained strong relationships with key opinion leaders to ensure access to the latest medical information and insights.
• Liaised with other healthcare professionals to develop comprehensive patient care plans and provide highest quality of care.
• Supported clinical research projects by providing expert guidance on study design, data analysis, and interpretation of results.
• Exercised leadership capabilities by successfully motivating and inspiring others.
• · Medical writing- prepared and vetted literature for internal/ external stakeholders and assisted in approvals at Veeva-vault to ensure compliance to worldwide regulatory/medical standards
• Cross functional activities with various business segments and liasoning with Regulatory affairs and Quality Assurance

• Participated in quality assurance audits, identifying areas for improvement and implementing corrective actions to maintain high standards of care in the department.
• Provided and managed direct patient care by conducting laboratory examinations, evaluations and assessments to determine diagnosis.
• Handling Haematology, serology, clinical pathology, histopathology, cytopathology, immunology, biochemistry, clinical chemistry, flow cytometry, special tests.

• Managed the whole laboratory services, reported haematology, cytopathology, serology, biochemistry, clinical pathology

• Histopathology, Haematology, Emergency laboratory duty, Blood bank, Cytology, Immunohematology, Flow cytometry
• I was involved in teaching undergraduates (MBBS, BDS), DMLT students, BPT students, nursing students.

• Facilitated seamless transitions of care for patients by coordinating with physicians, nurses, and other healthcare professionals across various departments.
• Improved patient outcomes and delivery of care through improved clinical quality processes.
• Assisted senior physicians and surgeons during assessments, examinations and surgical interventions.
• Enhanced patient satisfaction with thorough assessments, diagnoses, and treatment plans.

House intern on roster basis in all specialties and disciplines at Rajindra Hospital, hospital attached to Government Medical College, Patiala