Sunil Thaker *, Kline Road

Hillsborough, NJ *****

Cell: 908-***-****

Cell: 732-***-****

Email: adrncr@r.postjobfree.com

Objective: A Challenging growth oriented position for Quality Manager

Experience:

011/12- Present G & W Laboratories, South Plainfield,NJ

Quality In charge In Analytical department (QC) 2nd Shift

Manufacturing of Ointment, Tropical solution and Cream

Supervise the chemists in the group and as a mentor for staff.

Review SOP and testing procedures. Review Data for testing work all

the chemist

Allotment of work and accountability of their day to day work

GC testing activity new method development activity

HPLC& GC testing activity new method development activity

In-process sample.

Work on CAPA for all quality OOS investigations

USE RCAA tool and Quality tools like QMS and 6S

4/07-08/12 Aurobindo Pharma USA, Inc. Dayton, NJ 08810

Group Leader In Analytical department (QC)/ Principal Chemist- A

Supervise the chemists in the group and as a mentor for staff.

Allotment of work and accountability of their day to day work

GC testing activity new method development activity

Perform method transfer work for the New projects on GC and HPLC for ANDA projects

Review and Compilation analytical data for regulatory filing as per ICH guide lines

In house SOP & STP preparation as per current USP, NF, cGMP, cGLP Handling of Laboratory events, Investigations/OOS/OOT, Review QC reports/Documents/Laboratory data.

06/99-04/07 Par Pharmaceuticals Inc., Spring Valley, New York

Scientist- II-Quality Control

Perform chemical testing of pharmaceutical actives and inactive raw materials utilizing UV Visible and FTIR, Spectrophotometers, particle size analysis utilizing Malvern Particle Analyzer and Wet Chemistry Testing as per USP and In-House specification, Water Determination, Potentiometer Titration by Autotitrator . Dissolution test

Perform assay and Chromatographic purity tests using HPLC instruments, Knowledge of Total chrome, Turbo chrome and Millennium Software. Method transfers from R&D to QC

Perform Assay, Residual Solvents and OVI Tests on Gas chromatography Instruments.

Perform testing on LIMs Program.

10/98-06/99 Invamed Inc., Dayton, New Jersey

Chemist-Quality Control

Perform Chemical and Physical testing of Pharmaceutical Raw Materials utilizing UV- Visible and FTIR Spectrophotometers, DSC,(Melting Point Apparatus)

Physical tests for Tablets and Capsules.

01/94-06/98 Hester Pharmaceuticals, Ahmedabad, India

(In Collaboration with Maine Biological,, USA and Ghen Corp, Japan)

Assistant Manger- Quality Control

Sterility testing of vaccines and sterile diluents.

Supervision in manufacturing of sterile diluents for Poultry Vaccines.

10/83-05/94 Denis Chem. Laboratory, Ahmedabad, India

Assistant Manager-Quality Control

Managed Quality Assurance of medical Device and testing of chemicals and finished products for Intravenous Fluids.

· Writing of protocols for the products, In-process testing.

05/79-09/83 McGaw Laboratory, Ahmedabad, India

QC Chemist

Perform testing of plastic parts used for manufacturing of Medical Device used for Blood Infusion/Donor and different types of Catheters.

Perform Chemical tests, Sterility Tests and Biological Tests on animals for finish products.

Education : Gujarat University, Ahmedabad, India

(Bachelor Of Science In Microbiology & Chemistry)

Training: V.S.Hospital, Ahmedabad, India

06/78-04/80 Medical Lab Technician In Pathology

Professional Reference: More on request

Name Position company Phone

Mahesh Patel Sr. Chemist Par pharmaceutical, 908-***-**** Spring Valley, NY

Jonny Irofualla Manager compliance Sanofi- Pasteur, Swift water PA 973-***-****

G.Prasad Quality manager Aurobindo Pharma 732-***-****

Georgina Microbiology manager G & W laboratories, South Plainfield 317-***-****

Technical Certification:

Food & Drug Control Administration, Gujarat India

For The Testing Of intravenous fluid,Vaccines & Medical Devices.

SPECIAL: Familiar with US-FDA, cGMP, cGLP practices and ICH guidelines

Computer: :Microsoft Word, Excel Programme, Technical data archive Using computer Programme

Citizenship: USCitizen

Contact this candidate