Quality Control

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Michelle Han

*******@*****.***

***** ****** ***

Cerritos, CA, USA

Quality Control Manager / Consultant / Senior

Analyst

Summary of Professional Experience:

Expertise in pharmaceutical analysis and Good Manufacturing Practices. Experience control testing. in quality control department operation with excellent knowledge in quality Built pharmaceutical a successful company. career Quality Control laboratory in US leading brand and generic Experienced Procedures, SOPs. and knowledge of laboratory instruments ad Standard Operation Participated in method verification, method transfer, and method validation. Experienced regulatory affairs, in interacting quality control, with diverse quality areas assurance, of pharmaceutical R&D, and production. industry such as Dedicated training, and consultant workshops. with Quality Control area to providing knowledge, recommendation, Communicate fluently in verbal and written English and Myanmar. Career Highlight:

From extensive in senior Pharmaceutical regulatory pharmaceutical, Pharmaceutical laboratory management Quality affairs, industry. medical chemist Control pharmacovigilance industry. levels devices to Worked Laboratory from entrepreneurial Well personnel and understood successful healthcare experiences and market experiences senior teamwork junior industries. research and level level Quality throughout with analyst chemist experience quality, Assurance and situations the consultant, production, in years Documentation the to in higher gained R&D, Employment History:

2006 2013 – – 2013 2019 Quality USA Consultant, Bangkok, Control Thailand Quality Expert, Control, Teva KI Parenteral Pharma Asia Medicines, Tech Limited, Irvine, CA, 2

2019 Practical Quality - Present Control Experience: Freelance Yangon, Myanmar. Consultant for Pharmaceutical industry, CA, USA, and Teva Parenteral Medicines, Irvine, CA, USA.

Managed diagnosis, performed laboratory instruments Quality treatment procedures, tests. and Ensure work Control and area. including compliance prevention laboratory maintaining by with of disease. overseeing government the Verify, cleanliness laboratory requirements, record of and procedures lab report equipment, hospital lab used results policies in the on and all Key Contributions:!

• • • • • • • • • • Schedule/reduce into Ensure Assess and Demonstrate Oversee Wide compliance Experience Solid products. Familiar process. Documentation Well resolve work. versed Dosage, exposure any cycle all instrumental with plan testing analytical in areas by in time; flexibility Sterile laboratory cGMP generation, laboratory determining to system, is in quality monitor conducted a regulated volume or pharmaceutical analyses in SOP’s, instrumental analysis control, adapting testing maintenance process, the parenteral, analytical cGMP, according using root and for quality to progress cause cleaning HPLC, GLP problems, assign changing manufacturing and Large laboratory assurance, to reviews, and GC, cGMP revision work and validation volume implementing UV/business coach metrics, requirements. to and VIS, in regulatory maximize of environment. pharmaceutical parenteral, and FDA SOPs, and in needs. and mentor support regulations. FTIR preventative specifications, design effectiveness affairs, as and staff of required. feedback manufacturing Oncology industry validation, to investigate actions. and loops - Oral and

• • • • • • • procedures, systems. Expertise instrumental or Perform Participate Knowledge reports Knowledge Lyophilized Participate Knowledge compendia in trend in cGMP in in of of of products, batch testing methods Laboratory the chemical advance writing (analysis WHO,pharmaceutical internal records, of USP, and and bulk, and analytical for testing space EP, audit reviewing oncolytic stability wet training, finished and of chemical ownership program industry. instruments oral BP)testing. products. OOS products, investigation . solid analysis, investigations, and program dosage support such and according procedures, stability forms, as to HPLC, external maintain and Sterile samples, to other UPLC, audits. SOPs, reports, cGMP Injectable documentation GC, using testing IC, laboratory. and FTIR, both products, deviation protocols, and

• UV-Excellent Vis. interpersonal, communication, managerial and organization skills. 3

Quality Control

KI Pharma Asia Tech Limited

Quality and objectives • • Control Compliance Auditing as Consultant outlined and Consulting Monitoring in work client (primarily cGMP, (contracts/quality WHO, control on agreements. teams EU, PIC/laboratory led s, by US Project FDA, and ISO) product Manager testing, to meet specific goals

• methodology conformance documentation maintenance, and and Training analytical compliance and workshops with used Method reports, practices audits) GMP's, to test validation Failure (in products, Good specific laboratory, and Practices and aspect investigations, complete transfer, Instrument of in laboratory Quality assessment Test Support results, qualification Control operations of for records, Laboratory, laboratory's Mock and such raw inspection as data, Good Analytical writing workshops.method validation, ) Fundamentals of OOS and investigation reports Key Contributions:!

• • • • • • Evaluate Evaluate Review Review Evaluate Participate analytical analytical laboratory proper written in site techniques procedures oversight methods, test OOS results reports methods programs, of and and product and standard reports validations, CAPAs. including analysis in operating compliance including internal and procedures. product with audits water set specifications. and analysis. specifications. laboratory Freelance • • • • • inspection. Review Review instruments. Review Review Interact Consultant laboratory laboratory instrument and with enhancing clients for instrument design Pharmaceutical specifications effectively organizational layouts qualification. to in for achieve purchasing industry optimum structures. project quality new goals. laboratory control operations. equipment and Self-employed

• • • Provide previous Chemist. Give organizations. Provide expert guidance training knowledge strategic on and cGMP and advice training working guidelines to local pharmaceutical experience pharmaceutical associated as companies, with Pharmaceutical companies Quality and Compliance. healthcare using Quality my Control 4

Education: • • • • • • Give analyses and Offer industry Assist efficiency Provide Provide management, the Evaluate latest Quality recommendations recommendations in recommendations a operation standards of safety training deep and pharmaceutical Assurance effective productivity understanding regulations and of and running resources. documentation communication on regulations. to daily improve on using in operations compliance implementation quality of activities pharmaceutical my regulatory strong control control. especially skills, associated with analytical and laboratory of compliance cGMP new regulations, for the with Quality regulations. ability pharmaceutical skills operations conducting and to control quality stay to ensure updated to laboratories a products. improve thorough on 2001-2006 Bachelor University of of Science California, (Chemistry)CA, USA., Skills:

Skill Name Skill Level

Analytical impurity determination Method Assays and Expert

USP, EP, ICH Guidelines Expert

Pharmacopoeia verification method

Expert

Analytical method transfer method validation and

Expert

Analytical instrumentation Expert

Instrumentation software application computer

Expert

Wet chemistry techniques Expert

Laboratory Testing & Reporting Expert

Technical SOPs, investigation deviation change reports. writing reports, control, skills and including Expert

Product release Expert

Chemical of (products, and SVPs Sterile OSD. and Injectable testing Lyophilized LVPs), and Oncology Products techniques products, Expert

5

Professional Development:

GMP and Quality Control

Year Topic Organized by

2006 Good Quality Manufacturing Control laboratory Practices in Teva USA Parenteral Medicines, 2006 Good Quality Documentation Control Laboratory Practices in Teva USA Parenteral Medicines, 2006 Analyst Techniques Qualification – Wet Chemistry Teva USA Parenteral Medicines, 2006 LIMS application system in qualification laboratory and Teva USA Parenteral Medicines, 2006 Safety laboratory oncolytic Practices laboratory – General in Quality laboratory Control and Teva USA Parenteral Medicines,

2007 Fundamentals Chromatography application of Liquid - HPLC and Waters Corporation, USA

2007 Empower Software and application Waters Corporation, USA 2007 Gas application, Chromatography and Chem-theory, station Software Agilent Technologies, USA 2007 Technical notebook, report, CAPA. writing OOS report, skills Deviation - Laboratory Teva USA Parenteral Medicines,

2008 Analytical method validation Teva USA Parenteral Medicines, 2008 Analytical method transfer Teva USA, Parenteral Medicines, 2009 Change system control and documentation Teva USA Parenteral Medicines, 2010 21 Manufacturing Pharmaceuticals. CFR Part 211 Practice Current for Good Finished Teva USA Parenteral Medicines,

2010 Guide Quality to Control inspections Laboratories of Pharmaceutical US FDA 6

2011 FDA Project Form 483 and Remediation Teva USA Parenteral Medicines, 2016 Laboratory Instruments Qualification Teva USA Parenteral Medicines, 2013 UHPLC application Waters Corporation, USA

2013 ISO/IEC 17025: Internal Quality audit Teva USA Parenteral Medicines, 2017 Cleanroom Testing & Certification ISPE Thailand and TIPA 2017 Contamination Aseptic, Sterile Products Terminally Risk Sterilized Assessment and in Non- ISPE Thailand and TIPA

2019

2024 - 2025

ISO 9001

Six Sigma

KIPA Pharma Alliance

Personal development

Instrumentation Competencies:

• Waters HPLC / UHPLC

• Agilent HPLC

• Agilent Gas Chromatography (GC)

• Dionex Ion Chrmatography (IC)

• Distek Dissolution Apparatus

• UV-Vis

• Infrared Spectroscopy

• KF Titrators and Coulometers

• Mettler Toledo Thermogravimetric Analyzer

• Beckman Coulter LS230 Particle Sizer

• Viscometer

• pH meter

• Osmometer

• Analytical and Micro balances

• Density Meter

• Refractometer

• Hunter Color Instrument

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Software Competencies:

• Empower Chromatography software

• Agilent ChemStation Chromatography software

• Chromeleon Software for Ion Chromatography

• Laboratory Information Management System, LIMS Labware software

• Microsoft Office

• Statistical analysis

Other competencies:

Excellent phone and email communication skills.

Ability to work effectively and efficiently in team environment. Ability to manage time effectively.

Ability to work smart to excel the projects in a timely manner.

Contact this candidate