Shafiqa Sultan
Srinagar
Summary
Detail-oriented Systems Validation Professional with 11+ years of experience in regulated healthcare environments. Expert in the end-to-end validation lifecycle, including defining user requirements, executing UAT, and ensuring compliance with industry regulations. Proven track record in conducting risk assessments, managing change control, and supporting audit readiness for complex software implementations. Adept at bridging the gap between business subject matter experts and technical teams to deliver validated, high-quality systems.
Overview
14
14
years of professional experience
Work History
Principal Validation & QA Analyst
BigRio
08.2025 - Current
- Define and document detailed user requirements and functional specifications for healthcare data solutions, ensuring alignment with business needs.
- Lead validation and UAT efforts for cloud-based systems, drafting comprehensive test plans and scripts to ensure final outcomes meet regulatory standards.
- Participate in operational risk assessments, including change management reviews and periodic monitoring of serverless workflows.
- Act as an independent quality reviewer for system documentation, ensuring accuracy and compliance before production deployment.
- Support audit readiness by maintaining rigorous documentation of data ingestion processes and encryption standards in AWS environments.
- Collaborated with cross-functional teams to identify and resolve defects effectively.
- Developed and executed comprehensive test plans to ensure software quality and functionality.
- Led QA team in implementing best practices for testing methodologies and documentation standards.
- Mentored junior analysts on testing strategies and tools, promoting knowledge sharing within the team.
- Streamlined QA processes for better efficiency, implementing standardized test cases across multiple projects.
Wellness Break
Took Care of My Health
03.2025 - 08.2025
Specialist (Systems Validation)
Gustavo Infotech Pvt Ltd
10.2023 - 03.2025
- Coordinated with business subject matter experts to translate complex clinical data migration needs into actionable system requirements.
- Developed and executed UAT test scripts for high-stakes migrations, identifying edge cases and ensuring 100% data mapping accuracy.
- Managed change control documentation for API integrations, ensuring that system modifications did not compromise validated states.
- Facilitated corporate compliance by validating secure file transfers (SFTP/FTPS) within regulated healthcare frameworks.
- Streamlined communication processes between departments, fostering collaboration and reducing response time.
- Analyzed data trends to inform strategic decision-making and optimize project outcomes.
- Developed and executed training programs enhancing staff productivity and knowledge retention.
Manager, Quality & Systems Validation
Bixan
01.2023 - 10.2023
- Directed the validation of database-driven applications, performing periodic reviews and administrative maintenance monitoring.
- Researched and authored validation content for system upgrades, ensuring a seamless transition between legacy and cloud-based sandboxes.
- Utilized SQL to perform data integrity audits, verifying that system features accurately reflected documented business processes.
- Developed strategic initiatives to streamline workflows and improve team collaboration.
- Oversaw daily operations to enhance productivity and efficiency across all departments.
- Coordinated cross-functional teams to align project goals with organizational objectives.
- Implemented process improvements that reduced operational delays and enhanced customer satisfaction.
- Conducted regular performance reviews to mentor staff and elevate service standards.
- Analyzed operational data to identify trends and recommend actionable solutions for optimization.
Head of Quality Assurance & Compliance
Expentor
08.2019 - 01.2023
- Ensured organizational compliance with healthcare domain requirements through rigorous manual testing cycles and vulnerability assessments.
- Developed synthetic data strategies to facilitate UAT while maintaining strict adherence to PII/PHI privacy regulations.
- Supported customer audits by providing requested documentation and evidence of validation life cycle adherence.
- Mentored team members on best practices in quality management and continuous improvement methodologies.
- Analyzed data trends to identify areas for improvement in product quality and operational performance.
- Collaborated with cross-functional teams to align quality objectives with organizational goals and customer expectations.
- Conducted regular audits of production processes to ensure adherence to quality standards and procedures.
Senior Quality Analyst
STC
Jammu, India (Remote)
07.2017 - 08.2019
- Led quality assurance initiatives to enhance product reliability and customer satisfaction.
- Developed and implemented testing strategies for software applications, ensuring compliance with industry standards.
- Mentored junior analysts, fostering skill development and promoting best practices in quality management.
- Analyzed test results to identify trends, providing actionable insights for process improvements.
Quality Analyst
Lelafe IT Solutions
Bangalore (Remote)
06.2012 - 05.2017
- Conducted comprehensive quality assessments to ensure adherence to project specifications.
- Developed and implemented testing strategies to identify software defects early in the development cycle.
- Collaborated with cross-functional teams to enhance product quality and streamline processes.
- Analyzed user feedback and defect reports to drive continuous improvement initiatives.
- Led root cause analysis sessions to determine underlying issues affecting product performance.
- Analyzed quality and performance data to support operational decision-making.
- Developed and maintained quality assurance procedure documentation.
Education
Bachelor of Humanities Science -
University of Kashmir
Skills
- Computer Systems Validation (CSV)
- GxP
- HIPAA
- PII/PHI Data Integrity
- Requirement Gathering
- Functional Specifications
- Business Process Mapping
- User Acceptance Testing (UAT)
- System Integration Testing (SIT)
- Risk Assessment
- Change Management
- Vendor Documentation Review
- Jira
- SQL
- AWS CloudWatch (Monitoring/Audit Logs)
- API Validation (Postman)
- Test documentation creation
- Collaboration and communication
- Defect tracking mastery
- Technical writing proficiency
- Quality assurance metrics
- Agile methodology
- Version control systems
- Continuous integration
Timeline
Principal Validation & QA Analyst
BigRio
08.2025 - Current
Wellness Break
Took Care of My Health
03.2025 - 08.2025
Specialist (Systems Validation)
Gustavo Infotech Pvt Ltd
10.2023 - 03.2025
Manager, Quality & Systems Validation
Bixan
01.2023 - 10.2023
Head of Quality Assurance & Compliance
Expentor
08.2019 - 01.2023
Senior Quality Analyst
STC
07.2017 - 08.2019
Quality Analyst
Lelafe IT Solutions
06.2012 - 05.2017
Bachelor of Humanities Science -
University of Kashmir