Shweta Sharma

Lead lifecycle validation support for 15+ QC laboratory instruments and computerized systems in a GMP-regulated environment. Execute validation deliverables including URS, risk assessments, IQ/OQ/PQ, RTM, protocol execution, and final summary reports. Support change control, deviations, CAPAs, requalification, and validated state maintenance activities. Perform data integrity, audit trail, calibration, and preventive maintenance reviews to ensure ongoing compliance. Lead system decommissioning, upgrades, and remediation activities while maintaining validated state compliance.

Executed end-to-end Computer Systems Validation (CSV) for Veeva Vault quality systems supporting CAPA, deviations, complaints, investigations, and change control workflows in GMP environment. Authored and executed validation deliverables including URS, risk assessments, IQ/OQ/PQ protocols, RTM, test scripts, and validation summary reports. Performed functional testing, audit trail verification, electronic record reviews, and access control assessments to ensure FDA 21 CFR Part 11 compliance. Supported SaaS lifecycle management activities including vendor assessments, configuration reviews, release impact assessments, and regression testing. Managed change control activities including impact assessments, documentation updates, and validation re-execution where required. Collaborated with QA, IT, and business stakeholders to maintain validated state and inspection readiness of regulated systems. Participated in periodic reviews and continuous improvement initiatives to streamline validation processes while maintaining compliance.

Executed IQ/OQ/PQ qualification of QC laboratory instruments including HPLC, GC, dissolution systems, and UV-Vis spectrophotometers supporting GMP manufacturing operations. Developed and maintained validation lifecycle documentation including URS, protocols, RTM, discrepancy records, and final reports. Supported Empower CDS validation activities including audit trail review, user access verification, backup checks, and data integrity compliance assessments. Managed TrackWise change controls, deviations, and CAPA documentation supporting timely closure and GMP compliance. Performed calibration reviews, preventive maintenance verification, and equipment readiness assessments prior to qualification execution. Supported laboratory relocation, instrument requalification, and startup readiness projects with minimal operational downtime. Coordinated with QA, QC, Engineering, and external vendors to resolve instrument issues and maintain validated state.

• Supported accreditation readiness activities by reviewing public health programs against regulatory and accreditation standards. • Assisted with documentation reviews, process mapping, and gap assessments to support compliance initiatives. • Collaborated with cross-functional public health teams to improve documentation accuracy and readiness.

• Supported COVID-19 response initiatives including contact tracing, exposure notification, and public health education. • Assisted in data tracking, documentation, and reporting to support infection control and community safety. • Promoted public health guidelines, safety protocols, and compliance with state and federal COVID-19 regulations.

Worked as general trainer for ielts and conducted various workshops to enhance vocabulary and English speaking skills

1. licensed dental practitioner and hold meritorious achievements in my academic and clinical background. 2. Actively, doing healthcare administration . 3. Attended and lead various awareness camps and workshops to motivate and aware people for dental diseases

• Graduated with a perfect 4.0 GPA • Completed extensive academic and applied projects focused on healthcare quality management, regulatory compliance, process improvement, risk management, and healthcare operations • Developed strong analytical, documentation, and compliance-focused skills directly applicable to GxP, CSV, and quality system environments • Applied data-driven methodologies to improve operational efficiency, patient safety, and regulatory alignment

Completed comprehensive clinical and academic training in dentistry with strong performance across foundational sciences and advanced clinical practice. Recognized for outstanding academic achievement and clinical excellence, including receipt of the Anatomy Award. Developed a strong foundation in patient safety, clinical documentation, diagnostic accuracy, and evidence-based decision-making. Gained extensive hands-on experience in oral pathology, diagnosis, treatment planning, and full-mouth rehabilitation, fostering a disciplined, quality-focused, and patient-centric approach that continues to inform my work in regulated healthcare and quality systems.