Hang

Validation Specialist @Cpi

Glasgow, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Mar 2019 — Present

Validation Specialist @Cpi

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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

2006 — 2008

UCL

Doctor of Philosophy - PhD

2004 — 2006

University of Strathclyde

Doctor of Philosophy - PhD

1996 — 2001

University of Pharmacy and Medicine, Ho Chi Minh City

Bachelor with Honors in Pharmacy

SKILLS

Quality AssuranceIch GuidelinesBiotechnologyRegulatory RequirementsPharmacovigilanceQuality SystemGampPharmaceuticsFormulationCgmp ManufacturingBiopharmaceuticalsCleaning ValidationPharmaceutical IndustrySopFdaChange ControlAnalytical Method Validation21 Cfr Part 11Regulatory SubmissionsAnalytical ChemistryCgmp PracticesLife SciencesDissolutionIso 13485Sterility AssuranceSterilizationEquipment QualificationRegulatory AffairsLifesciencesQuality AuditingAseptic ProcessingComputer System ValidationValidationCapaPharmaceutical ManufacturingQuality by Design

ABOUT HANG

Experienced pharmaceutical scientist with a strong background in pharmacy and drug…

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Hang — Validation Specialist at Cpi in Glasgow, GB | Unifers