Sindhura Mamduri

Responsibilities

Risk and Governance Framework

• Created a comprehensive framework to manage AI use cases ethically, and mitigate risks. This included controls for risk management, deployment strategies for regulated and non-regulated use cases, and comprehensive documentation for regulatory compliance.
• The framework comprised SOPs, handbooks, guidelines, risk assessments, templates, risk taxonomy, control catalogues, training materials, and processes.

Project Management and Delivery

• Oversee the planning, execution, and delivery of software development projects.
• Collaborate with stakeholders to understand requirements, set project goals, and define the scope.
• Develop and manage project plans, timelines, and resource allocation.
• Monitor project progress, identify and mitigate risks, and ensure projects are completed on time and within budget.

Process Improvement and Optimization

• Evaluate and optimize the software development lifecycle, including processes, tools, and workflows.
• Implement and maintain effective development, testing, and deployment practices.
• Identify and address bottlenecks or inefficiencies in the software development process.
• Continuously seek ways to improve the team's productivity, product quality, and development velocity.

Responsibilities

Infrastructure and Tools Qualification

• Collaborated with product owner & development team to develop and refine user stories as per Gherkin framework
• Responsible for integrating quality by design approach and guiding the testing team to move to automation testing
• Responsible for reviewing automated test scripts, build artifacts, docker images and ensure quality in CI-CD implementations of different cloud technologies
• Well versed in achieving quality in Waterfall, Agile, DevOps methodologies including CI/CD and Containerization
• Supported the project teams in the implementation of CSA framework
• Implemented and maintained quality management systems (Root Cause Analysis, Corrective and Preventive Actions (CAPA) reporting and defect management) in adherence with industry standards
• Involved in continuous monitoring (Incidents, performance profile, security controls) as part of DevSecOps
• Involved in developing manuals/guidelines/procedures for the usage of enterprise-wide tools for e.g., JIRA, Jenkins etc

Stakeholder Management and Collaboration

• Effectively communicate with cross-functional stakeholders, including product managers, designers, and business leaders.
• Translate business requirements into technical solutions and ensure alignment between the development team and stakeholders.
• Represent the development team's progress, challenges, and needs to senior management.
• Foster strong relationships and collaborate with other teams and departments to achieve organizational goals.

Veeva Vault Quality suite

• Supported team in implementation and validation of Quality suite (Quality Docs).
• Responsible to review/author supplier assessment, user requirements, functional requirements, functional specifications and design specification, system risk assessment, validation plan, test plan, test cases, test/validation Reports, traceability matrix etc.

Mergers, Acquisitions and Divestitures

• Conducted gap assessments and due diligence of the acquired company’s capabilities on QMS.
• As part of post transaction activity, conducted prospective and retrospective validation of various applications (MES, DMS, etc.) under stringent timelines.
• Acted as a Liaison between Test/ Development team, Stakeholders to remove any impediments throughout the remediation activity.
• Participated in scrum ceremonies and weekly meetings to ensure risks identified were effectively mitigated.
• Developed procedures related to Quality Management
• System to manage the Supplier non-conformance processes, change control, CAPA and document management

SaMD

• Validated Medical Mobile apps and Medical Devices as per IEC 62304 and 21 CFR Part 820.
• Hands on experience on regulatory risk and testing methodologies like Human Factor Engineering, Formative testing, Summative Testing etc.
• Knowledge of validating AI/ML software as per NIST standards
• Faced internal audits and completed inspections with zero observations.

SAP S/4 HANA System

• Supported team in implementation and validation of SAP S/4 HANA (Direct Procurement)
• Responsible for preparing, reviewing and approving CSV deliverables before go-live.
• Assisted client and project teams on QMS processes like user access controls, change management, release management, incident and problem management, non- conformance and CAPA management, back-up and restore management, disaster recovery and business continuity plan.

Responsibilities

Oracle Argus Safety Database and GeneSpring GX

• Performed end to end validation of applications used in R&D and Pharmacovigilance space like Oracle Argus Safety Database and GeneSpring GX
• Authored, reviewed, and approved the validation plans, test protocols, validation reports, data migration plans and other quality/validation deliverables
• Performed GxP assessment, and data integrity assessment and proposed mitigation activities
• Experienced in reviewing key deliverables like User Stories, Functional Specification, Design Specification, Traceability Matrix, and Data Migration Plan along with Test Plan and detailed Test Cases Formulation and involved in Regression Testing and Performance Testing
• Also worked on the development of IQ, OQ, PQ Reports, SOP review & revision

Audit Engagements

• Performed and reviewed Periodic Reviews/Internal Audits/Supplier Audits of various system and their suppliers ensuring the accuracy, completeness, and compliance of validation deliverables by auditing their GxP systems
• Reviewed audit reports, including executive summaries, overviews, and detailed observations, and assisted in developing Corrective Actions for the observations identified in the audits/periodic reviews