Narendra Babu Srikantapuram

• As a Senior Test Lead within the pharmacovigilance domain's LSRA (LifeSphere Reporting and Analytics) Testing and Validation Team at ArisGlobal, I played a pivotal role in ensuring that our software solutions not only met but exceeded the rigorous standards set by regulatory bodies both nationally and internationally
• My role was instrumental in auditing, consulting, and managing the quality assurance processes, directly contributing to the enhancement of patient safety and efficacy of medicines.
• Developed training programs for new hires, accelerating their integration into the team.
• Delivered high-quality releases under tight deadlines by prioritizing critical tasks and adjusting resources accordingly.
• Actively participated in Agile planning sessions, providing valuable input on test scope and effort estimation.
• Championed knowledge sharing among team members through regular presentations and workshops on best practices in software testing.
• Streamlined testing processes for increased efficiency and reduced project timelines.
• Enhanced software quality by implementing effective test strategies and test plans.
• Reduced defect leakage by establishing rigorous testing procedures and standards.
• Mentored junior team members, fostering a collaborative work environment and enhancing team performance.
• Optimized resource allocation, assigning appropriate testers to specific projects based on expertise and skill set.
• Successfully identified areas for process improvement, leading to streamlined workflows and improved communication between teams.
• Conducted periodic reviews of test cases to ensure relevance and accuracy as specifications evolved over time.
• Collaborated with cross-functional teams to identify potential risks, resulting in proactive mitigation strategies.
• Increased customer satisfaction through thorough validation of user requirements before release.
• Implemented automation tools, reducing manual testing efforts and increasing overall productivity.
• Ensured compliance with industry standards by conducting regular audits of test documentation and processes.
• Spearheaded root cause analysis of issues discovered during testing to facilitate prompt resolution by development teams.
• Fostered open lines of communication with stakeholders at all levels, ensuring transparency regarding progress on deliverables.
• Optimized test cases to maximize success of manual software testing.
• Worked closely with different departments to develop innovative solutions to functionality issues.
• Improved product reliability with comprehensive end-to-end system testing.

Leadership in Quality Assurance: Spearheaded the development and implementation of a comprehensive quality assurance strategy that encompassed all phases of the product development lifecycle. This involved leading a team of QA professionals in conducting thorough audits, identifying process improvements, and ensuring compliance with global pharmacovigilance regulations.

Regulatory Compliance Mastery: Ensured strict adherence to national and international pharmacovigilance requirements, including the preparation, review, and execution of Operational Qualification (OQ) and Performance Qualification (PQ) protocols. My efforts guaranteed that our systems and processes complied with all regulatory standards, thereby mitigating risks and safeguarding patient health.

Audit Execution and Management: Managed a rigorous audit program that assessed both internal processes and external service providers. This involved planning, conducting, and reporting on audits, as well as liaising with stakeholders to address findings. My adeptness at interpreting audit findings and implementing corrective actions played a crucial role in Astellas' continuous improvement efforts.

Consultancy and Strategic Advisory: Provided GPvP (Good Pharmacovigilance Practices) expert advice to key personnel within the organization, assisting in the interpretation of health authorities' requirements and advising on their implementation. My consultancy services were vital in preparing Astellas for regulatory inspections, analyzing risks, and managing the implementation of readiness programs across departments.

Financial and Resource Management: Demonstrated exceptional skill in managing financial aspects related to QA activities, including budgeting for audits and controlling costs. My strategic oversight ensured that resources were efficiently allocated to maintain high standards of quality assurance while also achieving cost-effectiveness.

Stakeholder Engagement and Collaboration: Fostered strong relationships with cross-functional teams, regulatory authorities, and external service providers. My role involved coordinating the preparation, conduct, and follow-up of regulatory inspections, ensuring a unified and prepared response to any external audits or inquiries.

• Established and led a health-tech enterprise, underscoring an entrepreneurial ability to innovate and navigate through complex regulatory landscapes. - Developed tech-enabled health solutions, focusing on compliance and user-centric design, demonstrating an alignment with mission to bring value to patients through innovative science.

• Automated test cases using tools like Sahi Pro and Selenium, showcasing a strong foundation in software testing and quality assurance methodologies. - Led the design and execution of testing protocols, ensuring software solutions met high-quality standards.