General Manager Managing Director

Location:

Alor Setar, Kedah, 05150, Malaysia

Posted:

May 15, 2024

Contact this candidate

Resume:

**** ****** ***** **, ********* MI, ***** USA

+1-231-***-****

*-* * ***** ******, SUNGAI PETANI-08000. MALAYSIA.

Tel- +60 (0-19-478****

E-mail : ***********@*******.***

NACHEYAKALA ELUMALAI

Objective: Continuous Professional Development.

Working Duration:

December 1993

June 1997

Company Name/ Business Activity :

SM PHARMACETICALS

Manufacturing specialty of Pharmaceutical Finish Product such as Liquid, Creams,,Tablets, Capsules, Tablets, Injections and Others

SM CHEMICALS

Manufacturing specialty Pharmaceutical Raw Materials such as Erythromycin Group, Dexamethasone, Trimethoprime, and Others

Location:

Sungai Petani,

Malaysia

Designation : CHEMIST

Reporting To :

General Manager & Managing Director

[Job responsibility/ Equipment Handled /Achievement]

Microbiological & Chemical Lab Set up

Analyzing and monitoring -incoming, in process and finished product

Standard Operating Procedure – Development as per BP,USP,BPC,IP, JP,NPCB and others.

Testing of samples for evaluation of new products registration ( NPCB)

Testing of samples for evaluation from new suppliers

Research and development for new Product

Data analysis of the products and quality reports

Microbiological work such as MLT, LAL, Microbiological assay and others

Carrying out testing of Pyrogen for the Rabbits colonies, Toxicity & Safety for the mice colonies

Conducting Stability Study & Accelerated stability study in all aspects.

Chemical analysis

Dissolution Test Method development by using in Vivo and in Vitro testing method for New slow release Tablets/capsule.

LAL on Gel Clot and Kinetic Chromogenic Testing Methods for Pyrogen

Performing sterility test in Clean room Class 100

Preparation for Costing & Tender Quotation for all Pharmaceutical product

Preparation of registration document for oversees & Malaysia registration ( e.g. Vietnam,Myanmar, Singapore, Thailand, Nigeria & others )

In charge of the Quality Team and overall responsible in day to day quality activity in Chemical, Biological and Toxicology laboratory

Performing Audit Internal & External

Handling HPLC, GC, FTIR, UV, Karl Fisher, Specific Optical Rotation, Reflective Index, Density, Dissolution, Potentiometric Titrator, Hardness Tester, Friability, Microscope, Viscosity, IC, disintegration etc.

Setup of Chemical & Pharmaceutical Plant with Laboratory for Chemical & Biologica Testing and System Audit

Preparation of Pharmaceutical document for oversees & Malaysia registration ( e.g Vietnam, Myanmar, Sudan, Singapore, Nigeria, Thailand & others )

Establishing Testing Method for New Product for Pharmaceutical & Chemical Product.

Helped company to save 200K from product recall after the research work on the testing the content of potassium in penicillin tablet which was supplied to KKM. The research work was carried out by me at USM witnessed by the Prof. Dr. Ahamad / pharmaceutical faculty.

Working Duration:

August-1997

December-2001

Company Name/ Business Activity :

MNR. SCIENTIFIC (M) SDN. BHD.

oManufacturing specialty for Ultra – Pure Chemicals such as Solvents, Acids, Strippers, Etchings,Blends & Others for semiconductor industry

oMicro cleaning of caddies / trays for disc drive industry

Location:

Sungai Petani,

Malaysia

Designation : Quality Assurance Engineer & Senior Analytical Chemist

Reporting To :

General Manager & Managing Director

[Job responsibility/ Equipment Handled /Achievement]

Laboratory setup, design & Looking after the QA Lab operation all under clean-room environment class 10 and 100.

Standard Operating Procedure Establishment and write up & Internal Lead Auditor

New Product evaluation and testing method development

New suppliers qualification & Auditor

Testing of Indirect Materials for evaluation

Quality Assurance for Incoming Material, In-Process Material and Finished Product

Handling Regulatory requirements

Process Management Plan (PMP) write up and proposals

Evaluation of product stability after the process

Performing Internal & Supplier Quality Audit

Performing distillation by using Buchi unit to purify the Industrial Chemical to Semiconductor grade

Qualification of Iron Exchange Resin, Molecular Sieves and Filters for the chemical purification to Semiconductor grade

Document preparation, Establishing & implementing for QMS & ISO/IEC17025 certification

Handling Inductive Couple Plasma Mass Spectrometer (ICP-MS) – HP 4500Plus, Distillation unit Buchi Liquid Particle Counter – PMS Liquilaz CLS 700, Gas Chromatograph –Shimadzu 14B and 17A, Potentiometric Titrator Mettler DL53, Atomic Absorption Spectrometer - Perkin Elmer, Karl Fischer Titrator – Metrohm 737 KF, Viscometer – Brookfield DV-I+, G. Atomic Absorption Spectrometer - Perkin Elmer and etc

Setup of Semiconductor Chemical & Micro Cleaning Operating Plant with Laboratory in Malaysia

QMS & 17025 document Preparation & Certification in MNR Malaysia.

Qualification of Equipment & Semiconductor Process in Malaysia

Developing Test Method for Ultra-Pure Chemical, Semiconductor Chemical & Micro Cleaning using

( ICPMS, HPLC, GCMS, FTIR, LPC etc)

Qualified to Operate Inductively Coupled Plasma Mass after certification from HP from Little Falls, Delaware, USA

Qualified to perform Processes activity, Testing,SPC for Semiconductor Chemical at ACSI, Carrollton, Texas USA

Working Duration:

August-1998

December-2001

Company Name/ Business Activity :

MNR. SCIENTIFIC (S) PTE. LTD.

oManufacturing specialty for Ultra – Pure Chemicals such as Solvents, Acids, Strippers, Etchings,Blends & Others for semiconductor industry

oMicro cleaning of caddies / trays for disc drive industry

oAssembly of ICF (Integrated Chemical Filters)

Location:

Science Park, Singapore

Designation : Quality Assurance Manager & Senior Analytical Chemist

Reporting To :

Managing Director

[Job responsibility/ Equipment Handled /Achievement]

Laboratory setup, design & Looking after the QA Lab operation all under clean-room environment class 10 and 100.

Standard Operating Procedure Establishment, Implementation & Maintenance.

New Product evaluation and testing method development

Testing of Indirect Materials for evaluation

Quality Assurance for Incoming Material, In-Process Material and Finished Product

Process Management Plan (PMP) write up and proposals

Evaluation of product stability after the process

Performing Internal & Supplier Quality Audit

Performing distillation by using Buchi unit to purify the Industrial Chemical to Semiconductor grade ppb tp ppt & ppz

Preparation of document for QMS & ISO/IEC 17025 certification

Providing Training on the ICF & Caddies

Handling all activity related to quality

Setting up Semiconductor Chemical & Micro Cleaning Plant with Laboratory in Singapore

QMS & ISO/IEC 17025 document Preparation & Certification in MNR Singapore.

Qualifying distillation unit in Germany

Development of Testing Method for Ultra-Pure Chemical, Semiconductor Chemical, Assembly

Of ICF & Micro Cleaning using ( ICPMS, HPLC, GCMS, FTIR, LPC& others)

Qualified to Operate Inductively Coupled Plasma Mass after certification from HP from Little Falls, Delaware, USA

Qualified to perform Processes activity, Testing,SPC for Semiconductor Chemical at ACSI, Carrollton, Texas USA

Working Duration:

January-2002 to

February 2004

Company Name/ Business Activity :

S.P. CHEMICAL SDN. BHD.

Specialized in : Laboratory & Industrial Chemical, Pharmaceutical chemical, Food Grad, Chemicals Solvent, Water Treatment Chemicals, Electronic Chemicals,

Location:

Kulim, Malaysia

Designation : Senior Chemist & QA Manager

Reporting To :

Managing Director

[Job responsibility/ Achievement]

Responsible on the day to day activity in the Organization

Providing Technical Support and Chemical Consultancy to customer

Research work on blending new chemicals

Handling regulatory requirements.

ISO 9001:2000 Implementation.

Ensure all product conforms to CPL regulation

Control use of IMTE, handling of IMTE in use and storage of IMTE

( Inspection, Measuring and Test Equipment )

Preparation of MSDS/CSDS (Material/Chemical data sheet) for more than 600 material

Ensure appropriate Safety equipments in compliance to safety regulation ( OHSAS )

Providing external training for our customer on Chemical handling, Safety,Waste Treatment and etc

Performing Internal & External Audit

ISO9001 Preparation of Documents, conducting training and lead to certification.

Preparation of More than 600 MSDS & Chemical Label as per standard

Helped in handling the chemical explosion of Hydrogen peroxide 20MT storage tank and came up with action at ELNA PCB to over come any future explosion by providing new designing storage

Conducting in house /public training for other consultants in Malaysia

for ISO QMS/EMS/HACCP on auditing, implémentation etc.

Doing Third party certification audit for certification bodies / Supplier audit / internal audit for EMS/QMS/HACCP.

Conducting Chemical Risk Assessment for the companies.

Worked as a consultant for more than 15 companies and lead to QMS/EMS/HACCP/OHSAS certification, with zero non conformity during the certification audit.

Working Duration:

February 2004 Till now

Company Name/ Business Activity :

CHEMSURF SDN. BHD.

Specialized in : Training Programs & Chemical Management for Laboratory & Industrial Chemical, Pharmaceutical chemical, Food Grade, Chemicals Solvent, Water Treatment Chemicals, Electronic Chemicals, PCB Chemical, Plating Chemical, Bio Organic Fertilizer and others.

Location:

Sungai Petani,Malaysia

Designation : Business Manager

Reporting To :

Managing Director

[Job responsibility/ Achievement]

Responsible on the day to day activity in the company

Work closely with Sales on the new requirement by customer

Holding Poison License B for the handling of poison drug

Handling all Import & Export activity in the company

Providing Technical Support and Chemical Management Training to customer

Research work on blending alternate chemicals to match customer sample.

Blended a chemical Alternate to Hydrogen peroxide

Preparation of MSDS( Material Safety Data Sheet ) for more than 600 material

Ensure appropriate Safety equipments in compliance to safety regulation.

Providing external training for our customer on Chemical handling, Safety,Waste Treatment and etc

Performing supplier Audits

Preparation of Training Material for several programs

Preparation of More than 100 MSDS & Chemical Label as per standard for Bio Organic Fertilizer & PCB chemical

Done private Training on ISO/IEC 17025 for laboratory and FSMS ISO 22000

Doing Third Party audit for Certification bodies, Conducting supplier audits for other companies and internal audit on various systems EMS/QMS/FSMS/HACCP/GMP etc. for other companies

Education

[Year Educational establishments ]

Aug- 1993

[Qualifying authority ]

University Kebangsaan Malaysia

Bach. Degree in Industrial Chemistry

Education

[Year Educational establishments ]

Oct -2004

[Qualifying authority ]

University Technology Malaysia.

Executive Diploma in Quality Management

Education

[Year Educational establishments ]

Sept-2005

[Qualifying authority ]

Warwick, UK under(UTM) University Technology Malaysia

Certified Quality Engineer (CQE) in Quality Engineering

LEAD AUDITOR Training

[Attented on ]

From : 07/05/2001

To : 11/05/2001

[Name of organization conducting training]

European Quality Assurance (EQA)

[Results]

Successfully Completed

[Title of course or training scheme]

Occupational Health and Safety Management System (OHSAS)

LEAD AUDITOR Training

[Attented on ]

From : 16/07/2001

To : 20/07/2001

[Name of organization conducting training]

NEVILLE CLARKE INTERNATIONAL

[Results]

Successfully Completed

[Title of course or training scheme]

Quality Management System (QMS)

LEAD AUDITOR Training

[Attented on ]

From : 10/01/2005

To : 14/01/2005

[Name of organization conducting training]

European Quality Assurance (EQA)

[Results]

Successfully Completed

[Title of course or training scheme]

Enviromental Management System (EMS)

Lead Auditor Training.

LEAD AUDITOR Training

[Attented on ]

From : 05/06/2006

To : 09/06/2006

[Name of organization conducting training]

SQC MANAGEMENT

[Results]

Successfully Completed

[Title of course or training scheme]

Medical Devices Quality Management System

(ISO 13485:2003)

Lead Auditor Training.

LEAD AUDITOR Training

[Attented on ]

From : 31/07/2006

To : 04/08/2006

[Name of organization conducting training]

BRS- International Registration Body /USA

[Results]

Successfully Completed

[Title of course or training scheme]

Food Safety Management System (FSMS)

22000 Lead Auditor Training.

Certification on Competance of individual - (ISO/IEC 17024)

Additional Personnel Achievement

-Preparation of HACCP Document & Certification for ( LAM SOON in JB ) with in 4 Months

Key Responsibility :

● Re- Setup of Laboratory analyst/Quality controller ( for Biological & Chemical ) in Malaysia & Singapore

● Train the company executives & Preparation of HACCP Documents

● ON – JOB Training Monitoring of system Critical Control Points and control as per the HACCP standard

● Effecting corrective and preventive actions on non conformities

● Advising the management on matters pertaining to GMP / GLP and HACCP requirement in the plant

● Training Lam Soon staff on and ensuring that they adhere to the Good manufacturing practices(GMPs)

● Training Lam Soon Quality department staff on and ensuring that they adhere to the Good Laboratory

practices(GLPs)

● Training the production staff on the various Critical Control Points for which they are responsible, and

the associated hazards

● On JOB Training in Identify hazards e.g., o Biological/microbiological contamination of product of

Unacceptable survival and multiplication of pathogenic microbes and unacceptable generation of

Chemicals, toxins or other undesirable metabolic products.

● Advising conformity of process material to set HACCP standards

● Ensuring proper grading, labeling and coding of product for ease of traceability

Additional Personnel Achievement

IRCA/UK Approved Auditor for ISO22000:2005

Preparation of Halal Certification for food and non-food product such as pharmaceuticals, cosmetics and health supplements including product registration.

Representing as a Lead Auditor for several Certification Bodies for ISO9001, ISO14001, HACCP, GMP, GLP, GHP, ISO 13485 and ISO 22000, etc.

Member of IEMA ( Institute of Environmental Management & Assessment ) UK

Associate Member of ASQ ( American Society for Quality ) USA

Provided Training and Auditing services for several companies in setting up the whole system. (QMS,EMS,HACCP,FSMS,GMP /GCP / GHP/GLP )

Audited on various codes for third party certification as Indicated in the list below listed below.

In 2004 implemented a HACCP system in Foodvest Industries (M) Sdn. Bhd., and lead to successful certification of HACCP. Who is 100% exporting confectionary products to Europe, Japan, US and Middle East.

SOME OF AUDIT EXPERIENCE & PREPARATION OF THE ISO/EMS/HACCP/FSMS/etc SYSTEM

ORGANI

STANDARD

SCOPE

Muchun Biotech Sdn. Bhd.

ISO 9001:2000

Manufacturing & Trading Organic Fertilizer

Torto Food Industries (M) Sdn. Bhd.

HACCP

MS1480:1999,

MS1514:2001,& GMP

FSMS :22000:2005

Manufacture if cookies & Biscuits, cakes, candies ^ Confectionary

Lamsoon Edible Oil Sdn.Bhd

ISO 9001:2000

HACCP

Manufacturing of Margarine, Oils, Soap, fats.

Go Huan Sesame Oil

ISO 9001:2000

HACCP

Manufacturing of sesame oil

Foodvest Sdn. Bhd

HACCP

MS1480:1999,

MS1514:2001,& GMP

FSMS :22000:2005

Manufacturing of Jelly, Pudding & Confectionaty

Pawada Food Industries Sdn. Bhd.

HACCP

MS1480:1999,

MS1514:2001,

& GMP

Manufacturing of Cordial, Coffee, Corbonated drinks, can drinks

Lee Fah Mee Sdn. Bhd.

HACCP

MS1480:1999,

MS1514:2001,& GMP

Manufacturing of dried & Instant Noodles

Amisan Product Sdn. Bhd.

HACCP

MS1480:1999,

MS1514:2001,& GMP

Manufacturing of all types of sauce, ketchup.

Thye Huad Chan (M) sdn. Bhd.

GMP & FSMS :22000:2005

Manufacturing of Rice Flour.

Rohaya Food sdn. Bhd.

ISO 9001:2000& GMP

Manufacturing of all types of sauce, ketchup.

Kart Food Industries Sdn. Bhd.

HACCP

MS1480:1999,

MS1514:2001,& GMP

Manufacture of Doughnut Steam Buns(pau), Roti, Spring Roll, Murtabak, Samosa etc.

Raviraj Sdn. Bhd.

ISO 9001:2000 & FSMS:22000:2005

Repacking of Milk Powder, Gee, Tea and Texturised Vegetable Protein ( TVP) Product

Glovelinke Sdn. Bhd.

ISO 9001:2000

Manufacturing & Trading of Gloves

Bodywear Sdn. Bhd.

ISO 9001:2000

Manufacturing, Distribution & Trading of Garments

Ichi-Ban Mould-Tech (M) Sdn. Bhd.

ISO 9001:2000

Design & Manufacturing of Tooling

Nawaeel Coating Sdn. Bhd.

ISO 9001:2000

Provision of spray coating process and Sub Assembly of automotive compnonts

Hanaraum (M) Sdn. Bhd

ISO 9001:2000

Manufacturing of Leathers Gloves

Ichi-Ban Plastic (M) Sdn. Bhd.

ISO 9001:2000

Plastic Injection Moulding

B Braun (1) Phama Division Malaysia

ISO 9001:2000

Manufacturing Pharmaceutical & Medical Device Product

Pharmmalaysia Sdn. Bhd.

GMP &ISO/IEC17025

Manufacturing Pharmaceutical Establishment of Document / GMP & ISO/IEC17025

SM. CHEMICAL Sdn. Bhd.

GMP &ISO/IEC17025

Manufacturing Pharmaceutical Establishment of Document / GMP

SM. BIOMED Sdn. Bhd.

GMP &ISO/IEC17025

Manufacturing Pharmaceutical Establishment of Document / GMP

Ranbaxy (m) Sdn. Bhd.

GMP & ISO/IEC 17025

Manufacturing Pharmaceutical Establishment of Document / GMP & ISO/IEC17025

B Braun (2) Phama Division Malaysia.

GMP & ISO/IEC 17025

Manufacturing Medical Device Product Establishment of Document / GMP & ISO/IEC 17025

YMY Resources Sdn. Bhd.

ISO 9001:2000

Provision for Infrastructure and Civil Construction work

Broadway Packaging

ISO 9001:2000

Manufacturing of pulp, paper products

Orna paper Industries

ISO 9001:2000

Manufacturing of Corrugated paper and boards

Quality Print (M) Sdn. Bhd.

ISO 9001:2000

Manufacturing of Packaging Material

KH-Base Engineering Sdn. Bhd.

ISO 9001:2000

Provision of building Construction work

Pokico Packaging

ISO 9001:2000

Foam packaging

Triopackaging

ISO 9001:2000

Vacuum packaging & bubble packaging

Prestige Packaging

ISO 9001:2000

Vacuum packaging & bubble packaging

Four pillars Industry

ISO 9001 & 14001

Manufacturing of labels, sticker

Impression Unlimited Corp.

ISO 9001 & 14001

Printing of all materials

. Richbox

ISO 9001 & 14001