Consultant

Name:                         Mastura Nordin

Contact no:                019-659 1775

Website:                     www.onlinehbb.com

Email address:          mastura@onlinehbb.com/mn.mastura@yahoo.com

 

Qualification:

Degree in Bio-Medical Science, Faculty of Allied Health Sciences,

Universiti Kebangsaan Malaysia.

( B.Biomed.Sc.[Hons.] )

 

Experience:

1998 – 1999                Assist in R & D work at UKM for (subject matter)

 

1999                            Involves in laboratory work in Path-Lab of Mahkota Medical Centre, Melaka, dealing in various testing of Medical specimens for diagnostic purposes

 

1999 – 2000                Work in In-Vitro Fertilization (IVF) lab of Kotra Pharma.

  • Deals with production of sterile media of 2ml in 10ml vials; batch size 300 vials.
  • Conduct microbial test; total plate count.
  • Conduct R & D related tests: sperm count, pH, osmolality, etc, of semen samples.

 

1999 – Aug 2004         Production Executive – Sterile and Cephalosporin, Kotra Pharma (M) Sdn. Bhd.

  • Involve in planning and design of sterile production facility
  • Assist Plant Manager to set up sterile dept. operation.
  • Qualification of sterile facility, including HVAC system, steam, compressed air system, water-for-injections system, clean rooms, sterilizers, depyrogenation oven, and related equipment.
  • Actively participate in all sterile process validations including media simulation run for aseptic processes.
  • Schedule and manage operation (production of sterile powders and gels)
  • Conduct training to staff in sterile dept. and occasionally from other depts.
  • Responsible in assuring the effectiveness of the Quality Assurance in Sterile Department.

 

Sep 2004- Jan 2005   Consultant/ Trainer, Applied Chemie (M) Sdn.Bhd.

  • Give trainings related to cGMP
  • Conduct Qualification and Validation activities
  • Conduct ‘third party’ audit on client’s premises
  • Conduct research in subjects related to pharmaceutical industries and product produce by clients.

 

Feb 2006- July 2011   Operation Manager, A1 Consultancy & Integrated Services Sdn Bhd

  • Managing the operation department
  • Perform job as Consultant/ Trainer
  • Assist in administration and account department
  • Assist in preparation and planning design of new pharmaceutical factory
  • Building up documentation system for clients
  • Give trainings related to cGMP
  • Conduct Qualification and Validation activities
  • Product registration and up-dating
  • Regulatory issues
  • Conduct ‘third party’ audit on client’s premises
  • Conduct research in subjects related to pharmaceutical industries and product produce by clients.

 

Others:

  • Presented paper & assist on “ Basic & Concept of Quality/GMP and Product registration”; organized by Majlis Amanah Rakyat.-17-18th Apr 2006.
  • Presented paper on “Materials Handlings” at GMP workshop, Organized by Faculty of Pharmacy, UiTM.-22-23rd May 2006.
  • Presented paper on ‘GMP Documentation & Basic validation at GMP in-house training, organized by Universiti Kuala Lumpur, Malaysian Institute of Chemical & Bioengineering Technology, Alor Gajah Melaka, 15-16 July 2009.
  • Presented paper on ‘GMP Documentation & Basic Validation’ at GMP workshop, organized by Malaysian Biotechnology Corporation Sdn Bhd, 5th-6th Oct 2009.
  • Member of ISPE (International Society of Pharmaceutical Engineering) since 2006.
  • Attended various Trainings/Seminars. Amongst them are as follows:

            1999-2010                              

  • Limulus Amebocyte Lysate Seminar, organized by Choice-care Sdn.  Bhd.
  • GMP for Pharmaceutical Packaging Material Suppliers joint organized by MOPI & NPCB,MOH
  • S/S tubes & fittings for pharmaceutical Industry by CryoGas Tech. Sdn. Bhd.
  • Biological Indicators for Industries organized by Choice-care Sdn. Bhd.
  • Forum Bio Tech Scaling by Millipore
  • Total Marking and coding solution by Coding Tech (M) Sdn. Bhd.
  • ISO 9001:2000 internal Audit Training by CAI Oxbridge
  • Integrity testing for filters by PALL Cooperation
  • Basic of filtration & filter Intergrity testing by Sartorius (M) Sdn. Bhd.
  • HEPA filter Integrity test by Nextech Sdn. Bhd.
  • Microsoft word Level 1 by Cempaka Technology Sdn. Bhd.
  • International GMP training program joint organized by MOPI- NPCB- Interpharm Australia
    • Module 2- GMP Documentation & Records
    • Module 4- cGMP Engineering & Validation
    • Module 7- Facility, Materials & Environment control
    • Moduel 8- Process Control – Manufacturing & Packaging
  • Control of Quality & safety of Traditional Med & Health Supplements, organized by MOPI, NPCB.
  • Seminar Pakarunding organized by MARA.
  • Effective Communication & the Educator organized by PSMB.
  • Industrial Business Solution Seminar, organized by TM Bhd.
  • Current regulatory requirements for Health supplements organized by NPCB.
  • National GMP Seminar organized by NPCB,MOH.
    • Validation Practices(Module 5), NPCB training course, organized by MOPI.
    • Service Tax, organized by KDRM
    • Series of briefing by LHDN pertaining to company tax, rebates etc
    • Biotech & Biosimilar Products Workshop
    • Workshop On ‘online submission of Veterinary Products registration
    • National GMP Conference
    • Veterinary Products registration Seminar organized by NPCB.
    • GMP Seminar On Veterinary organized by NPCB.

 

Job references:

  • ACE Health Products Sdn Bhd, Selangor.
  • Amkey Malaysia Sdn Bhd, Kuala Lumpur.
  • Best World Lifestyle Sdn Bhd, Kuala Lumpur.
  • Biofact Life Sdn Bhd, Johor
  • BioNice Sdn Bhd, Johor Bahru, Johor
  • DXN Pharmaceuticals Sdn Bhd, Jitra, Kedah
  • Dynapharm Sdn Bhd, Penang
  • Ecolite Bio-tech Manufacturing Sdn Bhd, Batu Pahat, Johor
  • Farmina Bio-plus & Consultants Sdn Bhd, Batu Pahat, Johor
  • Formapac Sdn Bhd, Kajang, Selangor.
  • Halagel Plant (M) Sdn. Bhd., Kedah.
  • Herbal Science Sdn Bhd, Subang, Selangor
  • Infinitus International (Malaysia) Sdn Bhd, Selangor
  • KCK Pharmaceuticals Sdn Bhd, Penang
  • Malaysia Nuclear Agency, Bangi, Selangor
  • Matang Packaging Sdn Bhd, Kepong, Selangor.
  • Osmosis Nutrition Sdn Bhd, Nilai.
  • Phytomedicare Sdn Bhd, Bangi, Selangor
  • Pilot Plant, Kulliyah of Pharmacy, International Islamic University Malaysia, Kuantan,Pahang.
    • Pusat Pengajian Biosains & Bioteknologi UKM , Bangi, Selngor.
    • Ramedicare Sdn Bhd, Melaka
    • Seribu Dinar Trading, Selangor.
    • Shennong Animal (M) Sdn Bhd, Selangor.
    • Sunrider International (M) Sdn Bhd, Kuala Lumpur.
    • Sunward Pharmaceuticals Sdn Bhd, Johor Bahru, Johor.
    • Tropical Bioessence Sdn Bhd, Melaka.
    • Unza Manufacturing Sdn Bhd, Subang, Selangor
    • Uraz Corporation (M) Sdn Bhd, Melaka
    • Vitarite Pharmaceuticals Sdn Bhd, Melaka
    • Wijaya International Medical Centre, Petaling Jaya, Selangor.