Years Experience Manufacturing

HUI QING FANG (SELENA)

*** *********** ********. ********, **, L6V 4P5

Home Phone: 905-***-****, cell: 416-***-**** Email: ********@*****.***

PROFILE:

An Analytical Chemist with 10 years experience in the pharmaceutical industries, include working with variety of Raw Materials, In-process Bulk and Finished Products.

SKILLS:

.Familiar with current GMP, HPFBI, FDA, GLP regulations and SOP requirements.

.Familiar with LIMS

.Proficient in operating HPLC, GC, Particle Size Analyzer, Karl Fisher/Brinkman Auto Titrator, Dissolution Apparatus, FTIR and UV-Vis. Spectrophotometers and other analytical instruments.

.Able to troubleshooting the GC, HPLC and other instrument to ensure optimum performance.

.Strong analytical and problem solving skills.

PROFESSIONAL EXPERIENCE:

SGS Canada Inc (A Contract Lab.) Present

An analytical Chemist in Raw Material Department.

.Performed full test on lots of different Raw Materials according to USP, EP, JEP or Client Methods. Materials include: Solid, Semisolid and liquid (also Bio-sample).

.Experience lots of physical test and wet Chemistry such as ID, Limit, Assay, Viscosity, Water, TLC, RI, Specific Rotation, Specific Gravity, Organic extraction, purification using lots of different types of instruments

.Prepared and standardized volumetric solution and lots of in-house test solution.

Ciba Vision Canada Inc 01/2011-08/2011

(A Sterile Manufacturing for Lens Care solution and Ophthalmic Solution) (Contract)

QC Chemist

.Performed full test for in-processing solution in a limit time. Help the manufacturing to do adjustment in the batch if need.

.Tested Finished Products and Raw materials according to the In-house method and USP/EP. Tests such as: pH, Conductivity, Osmolality, TOC, Viscosity, Refractive Index, Hot stability, Assay by Manual / Auto Titration, ID, Assay or Relative substances by HPLC.

.Reviewed and released document.

Mylan Pharmaceutical ULC. (Previously Genpharm ULC.) 05/2001-06/2010

QC Chemist

(6 years in Finished Product Group and 3 years in Raw Material Group)

.Performed full quality tests for various Raw Materials, In-process Blend products and Finished drugs according to In-house Methods, current USP/NF or EP/BP requirements.

.Conducted ID, Assay and Content Uniformity and Related Substances by HPLC; Dissolution by HPLC and UV/Vis; Disintegration; Residual Solvent by GC-Headspace/Auto injector; Particle Size by Malvern Mastersizer 2000/ Malvern Analyzer 2600 and Nikon Microscope.

Performed ID/Impurities by TLC, ID by FTIR, Moisture and Assay by AutoTitrator, Specific Rotation by Polarimeter.

.Performed wet chemistry and physical tests for Active Raw Materials, Excipients and Finished products, such as: ID, Limit, Heavy Metals, Arsenic, LOD/ Sulfate Ash, Specify Gravity, Melting point, Hardness, friability, breakability, titanium dioxide and QA evaluation.

Conducted laboratory Investigation for OOS results.

.Operated HPLC/GC instrument with software: Empower, Waters Millennium programs.

.Familiar with dissolution equipments such as: Distek 2100, Vankel 700 and Sotax DT3.

.Documented all testing steps to ensure compliance with SOP, GLP and cGMP.

.Prepared Analytical Report and Spreadsheet using Microsoft Word and Excel.

.Trained new staff on testing with product protocols.

.Sent materials to Contract Lab. for testing. Communicated with Contract Lab. to ensure timeliness and accuracy of the analytical report.

.Used primary STD to qualify In-house special materials and use as secondary ( In-house) STD.

Ocean Nutrition Canada (ONC), Nova Scotia 1999-2000 (Two work terms)

.Conducted various wet chemistry testing on Fatty Acid (Fish Oil), including: Acid / Base Titration; Separation; Purification; Saponification, Iodization and standardization of Volumetric solution.

.Performed ID, Assay and Purity Check by GC auto injection or HPLC.

.Performed different strength organic synthesis to assist in improving the production processing.

.Inspected all packing material such as: bottle, cap, label and carton.

EDUCATION:

Chemical Laboratory Technology - Pharmaceutical Diploma 2001

(3 years program)

Seneca College, Toronto, Canada

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