Development Quality Control

DIPAK S. SONAWANE

e.mail:*********@**********.*** Ph.983-***-****

Introduction

M.Sc. in Analytical Chemistry with about four years of experience in

Research & development in API & bulk drug and about 15 years in Analytical

development in finished dosage form.

Currently working as a Group Leader-Analytical, R & D, Tulip Lab. Private

Ltd.Pune.

Career Objective

To learn and share complexities and challenges involved in pharmaceutical

industry, especially in the field of Analytical Development.

Career Profile

With over about 18 years of experience in Quality control, Analytical

development in API and FDF has the deftness in implementing & maintaining

quality system & GLP in Analytical development. Proven abilities for facing

regulatory audits. Effective communicator with excellent team management

skill & possess a result oriented attitude with analytical skill. Currently

serving as a Group Leader- Analytical development, formulation with Tulip

Lab. Private Limited.Pune

Carrier Progression

Tulip Laboratory Private Ltd. Ranjangaon.Pune

Group Leader: Analytical development, Finished Dosage Form from Feb.2013

Job Profile:

Responsible for Analytical method development for FDF and Validation as per

ICH guidelines and other regulatory requirement. Answering registration

queries and facing regulatory audits.

Leading a team of Analytical Scientists for the assign formulation for

Europe/ROW projects. Work with planning for Analytical method development,

validation & stress stability data.

Preparation & review of technical documents i.e. Specification, testing

procedure, Validation protocol, validation report, forced degradation

report & its respective raw data.

Analytical method transfer for finished dosage form.

Review of all technical documents required for Europe and Rest of world

filing for FDF.

Support to Regulatory for submission of required analytical data and to

answer the deficiencies.

Handling & investigation of LIF, FIR, OOS and deviation.

Preparation of audit response report and CAPA's

To monitor & review calibration of analytical instruments as per the

schedule & ensure the completion of PM activity.

Dissolution method development for immediate and extended release products.

Preparation & review of SOP's by following GLP.

Responsible for tracking and completion of change controls & CAPA's.

Responsible for imparting various types of technical trainings with group.

Leading a team of internal & external authorities audit like Ukraine.

Conduct the appraisal for team member.

Responsible for completion of Product development activities for submission

of dossier

in various countries.

Sandoz Private Ltd. Sandoz Development Centre, Kalwe Navi Mumbai.

( Sandoz, a generic pharmaceuticals

division of Novartis, is a world wise leader in generics.)

Principal Scientist: Analytical development, Finished Dosage Form from June

2001 to Jan.2013 (11.7 Years)

Job Profile:

Responsible for Analytical method development for FDF and API and

Validation as per ICH guidelines and other regulatory requirement.

Answering registration queries and facing regulatory audits.

Leading a team of Analytical Scientists for the assign formulation for

US/Europe/Japan/ROW/WHO projects. Work with planning for Analytical method

development, validation & stress stability data.

Preparation & review of technical documents i.e. Specification, testing

procedure, Validation protocol, validation report, forced degradation

report & its respective raw data.

Well versed with 21 CFR 11 & other global laboratory compliance

requirements.

Analytical method transfer for API and Finished dosage form.

Review of all technical documents required for US, Europe, Australia Canada

and Rest of world filing for FDF.

Support to Regulatory for submission of required analytical data and to

answer the deficiencies.

Handling & investigation of LIF, FIR, OOS and deviation.

Preparation of audit response report and CAPA's

To monitor & review calibration of analytical instruments as per the

schedule & ensure the completion of PM activity.

Develop and validate rapid analytical methods using Fast LC techniques.

Dissolution method development for immediate and extended release products.

Analytical method development & validation for residual solvents in drug

substance & drug products.

Provided analytical support for preparation of SOP's by following GLP.

Responsible for tracking and completion of change controls & CAPA's.

Responsible for imparting various types of technical trainings with group.

Leading a team of internal & external authorities audit like USFDA,EU &

internal global audits.

Conduct the appraisal for team member.

Responsible for completion of Product development activities for submission

of dossier for various countries.

Ensure quality & compliance & drive scientific discussion.

Merck Development Centre (I) Ltd, Taloja- Panvel

(API and its intermediate Manufacturing Organization.)

R & D Scientist, API Development. Sept. 1998 to May 2001 (2.8 Years)

Job Profile:

Responsible for testing approval & rejection of raw materials.

Analytical support to API R&D lab and trouble shooting to API production

department.

Responsible for cost-effective Analytical method development for related

substances, Assay, Residual solvents by using modern analytical techniques.

Isolation of unknown impurities in Drug substances by preparative HPLC as

per the regulatory requirements and its characterization.

Responsible for Qualification and Validation of equipment's with

preparation of protocols for DQ, IQ, OQ and PQ.

Preparation of documents require for DMF e.g. Control procedures SOP,STP,

Validation protocol, Method validation Reports etc.

Timely completion of Product development activities for submission of DMF.

Stability testing of API's and Intermediates as per regulatory

requirements.

Forced degradation studies for new developed API's and its intermediates.

To monitor & review calibration of analytical instruments as per the

schedule & ensure the completion of PM activity.

Actively involved in preparation DMF.

Aarti Drugs Ltd. Tarapur, Dist: Thane

(API and its intermediate Manufacturing Organization.)

QC Officer - Bulk Drugs & intermediate. Jan. 1997 to Aug.1998 (1.8

Years)

Job Profile:

Responsible for sampling & analysis of raw material and intermediates by

different chemical & instrumental method.

Responsible for Analytical method developments for intermediates & finished

products by using GC, HPLC.

Validation of Analytical methods for related substances, Assay, water

content as per ICH guidelines.

Stability testing of API's it's and Intermediates as per regulatory

requirements.

Preparation of SOP, STP, Analytical Method Validation protocol, Method

validation report, Control procedures, Specifications etc.

Chemtron Science Lab. Mahape, Navi Mumbai

(Manufacturing of calibration gas mixtures.)

R & D Chemist, August 1995 to Oct.1996 (About 1.0 Years)

Job Profile:

Responsible for development of GC method for Analysis of Calibration gas

mixtures by GC.

Responsible for analysis of pure gas, gas mixtures and calibration gas

mixtures by using GC and UV-VIS spectrophotometers

Actively involved in the manufacture of packed column used for GC.

Filling of pure gas and gas mixtures in different capacity of cylinders.

Preparation of Testing procedures, GTPs, Invoice etc.

Educational Credential

Academic Profile:

Post graduate (M.Sc.) in Analytical Chemistry from Y.M.College Pune

affiliated to Pune University - 1993 with first class.

Additional Qualification:

Completed Advanced Certificate course in instrumental and chemical

analysis, conducted by S.P.College Pune and LAB INDIA - Perkin Elmer

Corporation in May to June 1996.

Personal Skill

Sincere, Self motivated, hard working & capable of working in deadlines.

Team player can motivate others to achieve objectives. Effective

communicator can interact at all hierarchy levels effectively. Always

interested to learn new things.

Conferences/Seminars

Participated in various seminars on HPLC, GC, Quality systems, GLP, LIF,

OOS, deviation & CAPA. Participated in GC MS Interpretation seminar in

Singapore by Agilent Technology.

Participated a technical poster on Analytical Method Development by fast LC

in Sandoz R & D day.

Achievements

Awarded as "Best Development Team 2005" from Sandoz - India.

Received Spot Award for "Development, Validation and Transfer of cost

effective analytical method for impurities by RRLC for FDF" from Sandoz -

India

Received Spot Award for "Development, Validation and Transfer the

analytical method to Sandoz-Turkey for residual solvent" from Sandoz -

India

Personal Details

I am 44 years, married and stay with my mother, wife and one son. For a

challenging job I am mobile anywhere and willing to relocate. Currently I

am staying in Pune.

Residence:

Dipak S.Sonawane

A2/2:2Bhimashankar CHS Ltd.Sec.19A,

Nerul Navi Mumbai, India - 400706

e.mail: *********@**********.***

Phone: +919*********

CTC

Current CTC : 13.75 lakh/ annum

Expected CTC : About 20 to 25% rise.

Notice Period

Two months.

Declaration

I hereby declare that the above information is true & correct to best of my

knowledge.

Date:

Place:

(Dipak Sonawane)

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