Ashwini Kapu

A diligent and dedicated Computer System Validation professional with 8 years of comprehensive work experience, including 5 years of specialization in pharmaceutical CSV. I have refined my skills in application management and SDLC documentation, consistently ensuring compliance and driving results in pharmaceutical systems. My commitment to excellence motivates me to tackle new challenges and innovate solutions.

During my tenure at GlaxoSmithKline, I played a pivotal role in delivering critical Clinical EDC systems in Agile ways, I successfully navigated internal audits, facilitated end-to-end CAPA processes and excelled as a Business System Owner for diverse GxP and Non-GxP systems. Proficient in stakeholder and vendor management, I thrive in dynamic environments where I can contribute effectively and stand out. With a steadfast focus on CSV, I am eager to apply my expertise to contribute meaningfully to the organization's goals and foster mutual growth.

• Perform validation or qualification tests for new software releases or existing processes, equipment, or software following internal protocols or external standards.
• Supervise GxP and Non-GxP systems, and oversee the creation, review, and approval of various documents including validation master plan, VP, VR, URS, SRS, FRA, IQ, OQ, PQ, test scripts review, UAT, TM, smart Controls, SAP, SAR, Periodic compliance review (PCR), Compliance Report (CR), VSR, periodic compliance review, CAPA, RCA, ensuring adherence to quality management systems and regulatory requirements,  and managing document up-versioning. 
• Recognize risks, initiation, moderation, implement mitigation strategies, documentation, manage change requests, defects, and deviations, oversee up-versioning, and conduct retrospective or revalidation in Agile ways. 
• Maintain the quality system throughout SDLC according to various GXP requirements and ensure quality compliance through periodic inspections and audits. 
• Strategize, execute, and supervise in-process, process, and system-based internal audits, guaranteeing adherence to international standards and SOP's. 
• Serve as the business system owner, supporting stakeholders, third-party vendors, and customers for clinical development systems, and ensuring system suitability for intended purposes. 
• Ensure data integrity and consistently apply and maintain all data integrity policies and related principles.
• Perform quality checks on curated systemic literature reviews, meta-analysis, network meta-analysis, medical literature review, and medical research data.
• Ensure correctness of scientific research articles and digital evidence tables.
• Engage in data discovery and analysis to ensure data quality.
• Retrieve required data from the Bioportal database.
• Access databases including MedDRA, Uber anatomy, NCBI MESH, CHEMBL, Ensembl, Gene Ontology.
• Utilize resources such as Single Nucleotide Polymorphism Database, The Human Gene Mutation Database.
• Access ontology resources including Mammalian, Human and Mouse phenotype ontology, Biological assay ontology, cell line ontology, and cell ontology.
• Utilize Bioportal resources such as SNOMED-CT, NCI Thesaurus, and NCBI Taxon Databases.

• Masters in Biochemistry from CMR Institute of Management Studies, Bengaluru, India, India (2013-2015). 
• Bachelors of science degree in Combination of studies (Biochemistry, Microbiology and Biotechnology) from Yuvaraja's College, University of Mysore (2010-2013)
• Diploma degree in Nutrition and Health Education from Indira Ghandhi National Open University, University of Mysore (2013).