Ashwini Kapu

• Perform validation or qualification tests for new software releases and existing processes, equipment, or software following internal protocols or external standards.
• Supervised 2 GxP and 3 Non-GxP systems, overseeing creation, review, and approval of various documents including validation master plan, validation plan (VP), validation summary report (VSR), user requirements specification (URS), functional requirements specification (FRS), system requirements specification (SRS), performance qualification (PQ), operational qualification (OQ), test scripts review, user acceptance testing (UAT), traceability matrix (TM), smart controls, system access plan (SAP), system access review, Periodic compliance review (PCR), Compliance Report (CR), CAPA, RCA, ensuring adherence to quality management systems and regulatory requirements, and managing document up-versioning.
• Recognize risks, initiate, moderate, implement mitigation strategies, document, manage change requests, defects, and deviations, oversee up-versioning, and conduct retrospective or re-validation.
• Maintain quality system throughout SDLC according to various GXP requirements and ensure quality compliance through periodic inspections and audits.
• Conduct regular security audits to maintain compliance with industry regulations and guarantee adherence to international standards and SOP's.
• Serve as 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.
• Coordinate with external vendors during system implementations or upgrades, ensuring timely completion within project constraints.
• Cultivate professional working relationships with internal personnel, vendors, and suppliers.

Senior Scientific Analyst (2018-2021):

• Execute testing for computerized systems (CSV) and navigating through Software Development Life Cycle (SDLC).
• Comprehensive understanding of Pharmaceutical regulatory standards, encompassing 21 CFR Part 11, GAMP guidelines, and EU guidelines.
• Drafting validation documents such as Validation Plans, User Requirement Specifications (URS), Operational Qualification (OQ) deliverables, GxP checklists, and GAMP assessments.
• Ensuring strict adherence to project guidelines and ethical codes throughout due diligence period and project development stages.
• Analyze requirements and conducting thorough risk assessments to mitigate potential issues.
• Active participation in executing Operational Qualification (OQ) test cases and offering end-user support during performance Qualification (PQ) execution.
• Perform QA checks on curated systemic literature reviews, meta-analysis, network meta-analysis, medical literature review, and medical research data.
• Conducted in-depth literature reviews to identify gaps in current knowledge, informing direction of future research projects.
• Documented and reported test results after making graphical solutions and representations.

Scientific Analyst (2015-2018):

• Curate 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 Bioportal database access databases including, MedDRA, Uber anatomy, NCBI MESH, CHEMBL, Ensembl, Gene Ontology.
• Utilize resources such as Single Nucleotide Polymorphism (SNP) Database, Human Gene Mutation Database, and access ontology resources including Mammalian, Human and Mouse phenotype ontology, Biological assay ontology, cell line ontology, and cell ontology and utilize Bioportal resources such as SNOMED-CT, NCI Thesaurus, and NCBI Taxon Databases to retrieve data.