Ashwini Reddy kapu
Technical Analyst
Experience
Technical Analyst
GlaxoSmithKline
- Perform validation or qualification tests on new or existing processes, IT modules, equipment, Clinical trial software in compliance with internal norms or external standards.
- Resourceful in reviewing various documents, including VMP, URS, System Requirement Specification (SRS) and/or Functional/Technical Specification, Design Qualification (DQ), Risk Assessment (RA) with ALCOA CCEA, IQ, OQ, PQ, Traceability Matrix (TM), Compliance Report (CR), and Validation Summary Report (VSR), in accordance with regulatory requirements and quality management systems.
- Perform testing activities with Microfocus ALM and handle faults and deviations.
- Familiar with regulatory standards (such as FDA/GxP, records management, and disaster recovery).
- Proven expertise in risk management, FMEA, audit management, and periodic compliance reviews.
- Proficiency in change management and control procedures, deviation management, incident management, and CAPA escalation.
- Implementing a Quality System to meet GxP standards and ensure regulatory compliance through inspections, data review, and training.
- Conduct internal audits on processes and systems, prepare for external audits, and verify compliance with internal standards and SOPs.
- Develop and review SOPs and papers in accordance with regulatory norms.
- Organized and reviewed cGMP training records.
Scientific Analyst and Senior Scientific Analyst
Molecular Connections Pvt. Ltd.
- Conduct quality checks for systemic literature reviews, medical research reviews, meta-analyses, network meta-analyses, and digital evidence tables. Ensure scientific research articles meet client needs and company standards.
- Conducting data finding and analysis, guaranteeing data quality, analyzing safety data, and creating safety reports.
- Analyze research data to create tailored and relevant content for clients.
- Gain theoretical understanding on the practical application of medications in therapy, including their potential side effects.
- Continually learning about pharmaceutical medications, natural ingredients, and their biological functions.
- Expertise in retrieving data from Bioportal databases, including MedDRA, Uber Anatomy, NCBI MESH, CHEMBL, Ensembl, Gene Ontology, Single Nucleotide Polymorphism Database, Human Gene Mutation Database, Mammalian, Human and Mouse Phenotype Ontology, Biological Assay Ontology, Cell Line Ontology, Cell Ontology, Bioportal SNOMED-CT, NCI Thesaurus, and NCBI Taxon Databases.
- coding adverse events, responses, diseases, symptoms, and behaviors from clinical trial data utilizing databases.
- Assist with validation tasks such as application/module deployment, test script review, validation deliverables, and traceability matrix building.
- Managed internal audits, change requests, defects, deviations, and risk assessments, and provided SOP training and updates.
- Worked with cross-functional teams to align validation methodologies and escalate key issues, using both V-Model and Agile frameworks.
Summary
I am a dedicated professional with 5 years of expertise in Quality Assurance, Computerized System Validation (CSV), and Commissioning, Qualification, and Validation (CQV) in the healthcare and life sciences (HCLS) business, as well as 3 years in scientific data analysis. I am now doing a Master of Public Health at Arden University in Berlin. My interests include research management and quality systems in public health and biomedical areas. I have extensive experience working in cGMP and FDA-regulated environments. I am well-versed in regulatory frameworks such as FDA GxP compliance, GAMP5, 21 CFR Parts 11/210/211/820, QMS, GDPR, EU Annex 11, ICHQ9/Q10, ICH E6, ISO17025, and ISO14001.
Proficient in SDLC and STLC techniques (Waterfall, V-Model, Agile), as well as executing specifications, retrospecting, and re-validating results, risk assessments, and CAPA management. Experienced in document control, stakeholder engagement, and vendor management. Proven ability to design, coordinate, and ensure quality research activities, such as workshops, evaluations, and data validation. Expertise in scientific data analysis, systematic literature review quality control, and bioinformatics. Committed to safeguarding research integrity, supporting scientific leadership, and contributing to the strategic and operational growth of academic and clinical research programmes.
Experienced in curating and reviewing scientific literature, analyzing safety data, and coding clinical trial material in biomedical databases such as MedDRA, MeSH, SNOMED-CT, and CHEMBL. Competent in guaranteeing data quality, evaluating study findings, and providing client-specific, correct scientific insights.
Hands-on technologies and applications: clinical electronic data capture (EDC) systems, Central Designer, Inform, Inform Audit trail report (IATR), Oracle Suite clinical apps, ALM, and ServiceNow.
Languages
Education
Arden University
Master of Public Health · Public Health · Berlin, Germany
Bachelor of Science, Biochemistry, Microbiology and Biotechnology · Biochemistry, Microbiology and Biotechnology · Mysuru, India
CMR Institute of Management Studies
Master of Science, Biochemistry · Biochemistry · Bengaluru, India
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