NORHAFIZAH KHASIM
Simpang Ampat, Penang.,14120
Summary
A quality control professional with 17 years of experience in pharmaceutical companies with various pharmaceutical dosage form (Oral Solid, Oral Liquid, Transdermal Cream & Ointment and Parenteral Solution) with the current position as QC Manager.
Started a career as a chemist in analyzing pharmaceutical raw materials, packaging materials and finished products.
Extensive experience in pharmaceutical laboratory management and handling of laboratory instrument in compliance with cGMP & cGLP.
Familiar with Pharmaceutical Inspection Convention / Co-operation Scheme (PIC/S), Asean Guidelines, International Conference Harmonisation (ICH) Guidelines, US Pharmacopeia (USP), British Pharmacopeia (BP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP).
Overview
1
1
Certification
Work History
Pharmaceutical
Quality Control Laboratory
Ranbaxy (Malaysia) Sdn. Bhd. a Sun Pharma Company
Manager 2 –QC
Pharmaceutical Company
BBraun Medical Industries Sdn. Bhd.
Assistant Manager – Chemical Laboratory
Pharma Division
Teraputics Sdn. Bhd
QC Manager
Pharmaceutical Company
Education
Bachelor of Science - Industrial Chemistry
University of Technology Malaysia
Skudai, Johor09-2006
Skills
- Laboratory Management
- Technical report writing
- Documentation Review
- Internal Auditor
- Analytical Method Validation
- Pharmaceutical analysis by using analytical instrument
- SOP, specification & test method creation
Certification
Member of Malaysian Institute of Chemistry
Membership No. : M/3202/6008/11
COMPETENCIES
Laboratory Instrument
- Agilent HPLC – Chemstation, Cerity Software, OpenLAB CDS
- Thermo Ultimate 3000 HPLC - Chromeleon Software Ver 7.2
- Perkin Elmer Gas Chromatography Clarus 500 - TotalChrom Workstation Ver 6.3
- Perkin Elmer UV-Vis Spectrometer Lambda 35 - TotalChrom Workstation Ver 6.3
- Electrolab Friabilator (USP) EF- 2
- Electrolab Disintegration Tester (USP) ED-2L
- Electrolab Dissolution Tester (USP) TDT-08L
- Metter Toledo Karl Fisher Titrator V20
- Metter Toledo Titrator Excellence T5 with LabX Software.
- Thermo Scientific Nocilet iS5 FTIR
- Metter Toledo Analytical Balance XPE204
- Mettler Toledo Microbalance XPR2
- Metter Toledo pH Meter Seven Compact
- Polarimeter
- Viscometer
- Furnace
- Oven
- Incubator
- Laminar Air Flow MTT4 Micro-Tech
- Biosafety Cabinet Class II A2 Biobase
- Tomy Autoclave SS-325
Timeline
Pharmaceutical
Quality Control Laboratory
Bachelor of Science - Industrial Chemistry
University of Technology Malaysia
Member of Malaysian Institute of Chemistry
Membership No. : M/3202/6008/11
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