Hang
Validation Specialist @Cpi
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WORK HISTORY
Validation Specialist @Cpi
Glasgow, GB
My role as Validation Specialist includes:Documentation & Validation Leadership; Broad experience across validation functions, including authoring, reviewing, approving, and executing validation documentation such as:• Validation Master Plan (VMP)• User Requirement Specifications (URS)• System Impact Assessments & Risk Assessments• Validation Plans, FDS, FAT/SAT• Qualification protocols (DQ, IQ, OQ, PQ), summary reports, and handover forms• Facilities, utilities, equipment and computerised systems• QC analytical systems and methods• Led and maintained the site’s Validation Master Plan for all GxP systems• Conducted periodic reviews, re-qualification and data integrity assessments• Provided strategic guidance on validation, change control, CAPA, and deviation management• Trained new QA, validation, engineering and operational colleagues in quality and validation best practicesInspection & Compliance Support:• Supported internal self-inspections, and external audit including validation related vendor audits• Authored and reviewed SOPs and templates for quality and validation processes
EDUCATION
UCL
Doctor of Philosophy - PhD
University of Strathclyde
Doctor of Philosophy - PhD
University of Pharmacy and Medicine, Ho Chi Minh City
Bachelor with Honors in Pharmacy
SKILLS
ABOUT HANG
Experienced pharmaceutical scientist with a strong background in pharmacy and drug…
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