Yasinullah S.
Automation Validation Engineer @BioMarin Pharmaceutical Inc.
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WORK HISTORY
Automation Validation Engineer @BioMarin Pharmaceutical Inc.
US
EDUCATION
Sikkim Manipal University
Master's degree, Project Management
ABOUT YASINULLAH S.
Over eight years of diverse experience in Computer System Validation (CSV) and Computer System Assurance (CSA) and Equipment Validation.• Skilled in validating automation systems and conducting data integrity assessments.• Experienced with Electronic Document Management Systems (EDMS), Laboratory Information Management Systems (LIMS), and the Software Development Life Cycle (SDLC).• Strong background in Data Integrity, ALCOA++, 21 CFR Part 11 compliance, Risk Assessment, and Data Life Cycle (DLC) management.• Extensive expertise in creating, reviewing, and documenting SOPs, Work Instructions, Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, Summary Reports, and Change Control documentation to ensure FDA compliance.• Provided support for audits and inspections, ensuring projects are managed compliantly and project life cycle documentation remains complete and consistent.• Experience in Audit Trail review, RtRrport and PI Vision• Experienced in mentoring team members and guiding them in the development of SDLC deliverables.
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