Quality Assurance Manufacturing

Sachin Gupta

Email: *********@*****.*** Phone: (M) +91-976**-*****

Omkar Apartment, Flat No 5., Govind Nagar, Chowk No.1, Nashik - 422 009,

Maharashtra, India

Seeking challenging assignments at Sr. Scientist Level that would

facilitate the maximum utilization and application of my broad skills and

expertise in making a positive difference to the organization

. A seasoned R & D professional offering more than 7 years of experience

in the Pharmaceutical Industry, combining analytical skills with

business acumen to positively contribute to profitability

. Technically proficient with strong research aptitude backed with flair

for information mining and analytical mindset to present information

to enable critical decision making

. Business-focused and result-driven individual who promotes and

represents leadership, teamwork, integrity, accountability and

commitment

. Creative and forward thinking innovator with excellent analytical and

problem solving skills

. Persuasive communicator with unsurpassed interpersonal, influencing

skills and an outstanding work ethics

. Highly flexible, and adaptable individual who is adept in juggling

multiple projects with positive attitude

. Demonstrated ability to apply and correlate intensive and diversified

knowledge of scientific principles with consumer habits and practices

in broad areas of assignments

. Keeps abreast of business environment around as well as current issues

and changes in the industry regulations

CORE STRENGTHS

. Material Characterisation

. Analytical Method Development, Validations and Transfer

. Quality Assurance (cGMP, cGLP)

. Risk Based Approach

. Colloid & Inter-facial Science

. Troubleshooting Activities in Pharmaceutical Manufacturing Process

. Surfactant Chemistry

. Statistical Data Analysis

. Health, Safety & Environment

. Training & Mentoring

.

CAREER CONTOUR

Physical Properties Analyst - Technical Development, GlaxoSmithKline

Pharmaceuticals Ltd, Nashik (Oct'07 till date)

Key Deliverables:

. Establishing Material Characterisation Capability at Nashik TD.

. Currently leading the Material Characterization Dept and assessing the

physical properties (such as Particle Size, Powder Flow Polymorphism

etc.) of API & Excipients using wide range of techniques such as Laser

Diffraction, X Ray Diffraction, Thermal Techniques, Microscopy etc.

. Instrumental in developing Analytical Methods, perform validations and

method transfers.

. Key role in assessing the risk associated with the source change

activities of API and Critical Excipients.

. Performing Technical Reviews at Supplier site to assess the impact of

the source change on existing formulation process and inform to

stakeholders.

. Supporting various groups within GSK such as Particle Sciences,

Procurement technical & GSK primary sites worldwide on Physical

properties measurement expertise.

. Equipment Validation including Computer System Validation.

. Key role in writing Research articles and technical reports for

internal publication

. Instrumental in co-ordinating with Collaborators and Senior Management

in a multi-culture set-up to communicate project information on time

to meet business deliverables.

Projects:

#1: Giza Source Change Projects

. Actively supported the source change activity of 9 Bristol Myers

Squibb API by providing the Material Characterization of the API's.

. Successful in delivering recommendations on source change thus

achieving the key milestones

. Honored with 'President's Roll Of Honor' award

#2: Tablet Hardness Issue for a Key Formulation

. Successfully resolved the tablet hardness issue for the key tablet

formulation by identifying the root cause of the problem.

. Helped in reducing the cycle time on the manufacturing line.

. Further employed the multivariate analysis tool for predicting the

problematic batches.

#3: Off White API Issue

. Successfully identified the off white API issue by conducting the

technical review at supplier site.

. Critically reviewed the BMR's at supplier site and established the

root cause of off white appearance of the API which affected the

appearance of the tablets.

. Established that there was no link between impurities and the

increased solvent washing which leaded in considerable savings to GSK

on the cost of the API.

Research Scientist, Wockhardt Research Centre, Aurangabad, India

(Apr'06 - Aug '07)

Key Deliverables:

. Characterization of API for Particle size distribution by laser

diffraction, their method development and validation.

. Quantification of polymorphs in API and formulations by XRD, FTIR and

DSC.

. Characterization of API's by XRD, DSC and TGA.

. Compatibility study of excipients with API using DSC.

Noteworthy Credits:

. Highlighted the incorrect PSD reported for the BCS Class IV drug (Para

IV).

Research Associate, Ranbaxy Research Laboratories. Gurgaon, India

(Aug'04 - Apr'06)

Key Deliverables:

. Developed and validated methods for Particle Size Analysis by Laser

Diffraction for API's and Excipients

. API Characterisation by NMR & FTIR.

. Provide support to Chemical In process Lab by monitoring chemical

reactions by HPLC.

Noteworthy Credits:

. Successfully developed method for particle size for +10 API's

performed validation and transferred them to manufacturing sites.

R&D Chemist, Cipla Ltd., Mumbai, India

(Aug'99 - Sep'00)

Key Deliverables:

. Analyzed raw materials, in process goods and finished products by

appearance and quantitative analysis

. Operated and Calibrated instruments like UV-VIS spectrophotometer, GC,

HPLC, Dissolution Tester, Particle Size Analyzer, pH meter and

maintained documents as per cGLP & cGMP standards

ACADEMIA

. Ph D in Chemistry from Institute of Chemical Technology, Mumbai in

2004

. M Sc in Analytical Chemistry from Mumbai University in 1999

. B Sc from Mumbai University in 1997

TRAININGS

. Material Characterisation, Dartford, England

. Laser Diffraction, Malvern Instruments, England

. Introduction to Operational Excellency, GlaxoSmithKline, Nashik.

PUBLICATIONS

. "Adsorption of Different Surfactants at Carbon Black - Water

Interface"; Sachin D. Gupta and Dr. S. S. Bhagwat, J. Disp. Sci.

Techn, 2005.

PERSONAL DOSSIER

Date of Birth: 14th October, 1976

Linguistic Proficiency: English, Hindi and Marathi

Interests: Gadgets, Listening to music, Net Surfing, Traveling, Movies.

References: Furnished upon request[pic][pic]

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