Engineer Quality

NUPUR PRABHU

***********@*****.*** 443-***-**** San Francisco CA

SKILLS

● Experienced in FDA audits,CAPA, Quality Metrics, Root cause analysis, deviation handling, hazard analysis,Validation

● Hands-on experience: HPLC, UPLC, Polarimeter, GC, FTIR, CHNS/O Analyzer, Temperature mapping (freezers)

● Familiar with FDA regulations: 21 CFR Part 11, EU Annex 11, ISO 13485, IEC 62304, ISO 9001, cGXP (cGMP, cGCP, cGLP)

● Strong knowledge of Agile, JIRA, Trackwise,GQMS, MadgeTech, Sharepoint, Office Suite (Word, Excel, PowerPoint)

● Native proficiency in English, basic knowledge of French EDUCATION

Johns Hopkins University, B altimore, MD Dec 2014

Master of Science in Biotechnology

University of Mumbai, M umbai, India J une 2013

Bachelor of Engineering Biotechnology

EXPERIENCE

Collabera Inc, Basking Ridge, NJ A ugust 2017 - present Client: Abbott, D iagnostics Division, S anta Clara, CA Quality Engineer

● On-time completion of Quality (QA) engineering deliverables, Quality Approver, Certificate of Analysis Approvals

● Supporting site CAPA team with training, CAPA oversight, and CAPA deliverables; publishing CAPA metrics

● Initiating non conformances and CAPA investigation Quality Records in Trackwise,supporting Internal and External Audits

● Preparing Quarterly and Monthly CAPA Review Board metrics and Executive Management Review meeting minutes

● Provide support for ISOTrain(Electronic Training Management System) as a Subject Matter Expert for all site employees CS Bio, M enlo Park, CA A pril 2017 - August 2017

Provides peptide synthesizers and custom peptides to the life sciences community for 15+ years Validation Engineer

● Managed Quality Control equipment validation test cases; executed scripts for IQ, OQ, and PQ testing

● Trained Quality Control, Manufacturing, and Materials Management teams on Audit observations and SOPs

● Initiated CAPAs, Change controls and Deviations as part of an ongoing FDA audit

● Prepared Validation documents including SOPs, Validation Protocols and Requirements Traceability matrix

● Conducted Quarterly User Access reviews and System audit trail reviews for Equipments and Utilities Validation Associates LLC, Herndon, VA F eb 2015 - March 2017 Client: Eli Lilly and Company, I ndianapolis Device Manufacturing, Indianapolis, IN Senior Validation Engineer / C&Q Engineer

● Interacted with Lilly’s Quality team as well as OEM and Contract Manufacturers to resolve quality issues

● Produced test cases and FAT documents; initiated design review sessions and failure mode effects analysis

● Consolidated requirements document and Trace Matrix after soliciting feedback from key stakeholders Client: Terumo Cardiovascular Group, A nn Arbor, MI Senior Quality Assurance Engineer

● Identified quality issues including boundary/invalid entry for 200+ CDI and Heart Lung Machines for CAPA

● Conducted Root Cause Analysis and Impact Assessment for CAPA requirements; conducted periodic reviews

● Managed deviation handling including deviation investigations and assisted with Quintiles Audit findings

● Performed NPS Risk Analysis to assess 21 CFR Part 11 applicability and compliance for Heart Lung Machines

● Led team review of PVAM, PFMEA, RCOA, MWI documents, Test Method Validation Protocols and Reports

● Reviewed SOPs and User Manuals for equipments per FDA requirements; executed IQ, OQ, PQ scripts Client: Catalent Pharma Solutions, Somerset, NJ

Validation Engineer

● Led testing for Optel Serialization Solution across geographies including on-site visits to Illinois and Germany

● Prepared Validation Master Plan and support documents for Computer System Validation (CSV)

● Developed validation guidelines for GMP, GCP, and GLP practices; assisted with GAP analysis and Risk analysis

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