ChM. Rachel Gan
Chemist at SteriPack Contract Manufacturing- Claim this Profile
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English Professional working proficiency
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Chinese Native or bilingual proficiency
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Malay Professional working proficiency
Topline Score
Bio
Experience
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SteriPack Contract Manufacturing
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United States
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Medical Equipment Manufacturing
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100 - 200 Employee
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Chemist
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Aug 2017 - Present
Play my role and Swim as whole! Professional Membership - Certified IKM Chemist M'sia - Accredited Internal Auditor ISO13485 & FDA Responsibilities & Capabilities --> Responsible and overseeing medical device lab method validation and routine analysis. --> Improvise practices and QAQC based on GDP, GMP and GLP practice & quality system compliance --> Incoming (IQC), in process (IPQC) & final (FOQC) inspections, physical lab tests --> Involvement in method transfer, development & validation projects with statistical data analysis and result presentation --> Supervise subordinates, manage and equipment calibration activities --> Conducting and involvements in audits - regulatory, customer, supplier and internal audits related to production, material and process --> Problem solving and troubleshooting non conformances NC, corrective and preventive action CAPA issue Specialize in Instruments of :- ⚫Chromatography - GCMS ⚫Spectroscopy - FTIR, UV-Vis Workshops /Training / Experiences ⚫ISO 13485 Medical Device ⚫FDA ⚫Calibration Training ⚫Risk Assessment on Medical Device ⚫Sterilisation process ⚫Lean 8D Problem Solving ⚫Mettler Toledo Good Weighing Practice ⚫Agilent MH Masterclass Training ⚫ISO 13485:2016 Internal Audit Training ⚫Process Validation ⚫Calibration
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SGS
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Switzerland
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Professional Services
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700 & Above Employee
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Team Lead - Chemical
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Jan 2017 - Aug 2017
Professional Membership⚫Registered Chemist (Licentiate) by IKM ⚫Professional Member by MIFT MalaysiaFeel achieved in:⚫Performed data analysis on chemical testings (food, electronic, consumer products, environmental tests)⚫Validated numerous methods with GC and HPLC and UV-Vis testings⚫Improvise testings and QC⚫Involvement in lab audits for 2 years⚫Guided and trained 10 freshmens continuouslySpecialize in Instruments of :-⚫Chromatography - GCMS, GC-FID-HS, LC-UV/FL, LCMS, LCMSMS⚫Spectroscopy - FTIR, UV-VisWorkshops /Training / Experiences Regional ⚫Method Development Training in SGS BangkokLocal⚫Food Safety Workflow & Analysis Seminar by Thermo Fisher Scientific & MIFT ⚫Safe Talk and Tech Talk by HSE SGS ⚫Environmental Advanced Technology by Perkin Elmer
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Chemist
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Dec 2014 - Dec 2016
Tasks:• Providing lab testing services to clients on:1) E&E materials 2) Latex glove3) CARBs testings 4) Food (Plasticizers, Alcohol, Vitamins, Antibiotics)5) Toys (Plasticizers)6) Food Contact Material Test• Hands On Instruments:- GCMS, GC-FID-HS- UV-Vis Spectrophotometer- FTIR- LC-DAD-MS, LC-MS/MS, HPLC-UV/Vis/FL - Non destructive Testing such as Headspace, Purge&Trap Technology • Participated in:- Proficiency testing(PT) and Competency analysis- New method development tests based on potential markets and global needs (Currently for Vitamins, Steroids, Antibiotics and Pesticides, Water & Environmental)• Purchasing of chemicals and apparatus for lab needs. •Workshops & Conferences: -Statistics for Laboratory -Agilent Science and Technology Symposium'16- Perkin Elmer HPLC Training Workshop- MS ISO/IEC 17025:2005 Training-Joined Training of QA QC Procedures for Testing Labs-Introduction of the new MS by ABSciex 2016
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Education
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Universiti Teknologi Malaysia
Bachelor's Degree of Science (Hons), Chemistry