Quality Assurance Manager

BIO-DATA

NAME : Dr. KRISHNA KAMAL CHAKRABORTI

FATHER’S NAME : Late Mr. Shib Kamal Chakraborti

: 2nd February,1959

DATE OF BIRTH

SEX : Male

MARITAL STATUS : Married

PERMANENT ADDRESS : 40, Shibachal ; P.O. Birati

Calcutta 700 051 ; INDIA

Phone +91-33-253*****

PRESENT ADDRESS : Flat No. 2 A, Block E 3

Satabdi Vihar, Sector 52,

Noida 201301 (UP) ; INDIA.

Phone +91-120-*******

Mobile: +91-981*******

E MAIL : *******************@**********.***,

********@****.***,

EDUCATIONAL QUALIFICATIONS :

DEGREE UNIVERSITY YEAR CLASS

Panjab Univ., Chandigarh; India 1989 NA

Ph.D.

1st

Panjab Univ., Chandigarh, India 1983

M.Pharm

1st

Jadavpur Univ., Calcutta, India 1980

B.Pharm

INDUSTRIAL EXPERIENCES:

ORGANISATION POSITIO DURATIO RESPONSIBILITIES

N HELD N

Reckitt Benckiser Regional May, 2012 Quality In-charge of 4 plants in

India Ltd Quality to till date the region. ( India, Thailand &

Head, Pakistan)

Dev. Mkt.

Healthcare

Jubilant Life Head Oct.2005 to Establish Corporate QA

Sciences Ltd. Noida Corporate April 30, Function. Ensure GMP

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( UP ),India (Formerly QA 2012 compliance in all Formulation,

Jubilant Organosys Ltd) API, Chemical plants and R&Ds

Panacea Biotec Ltd., GM, March 2004 Creation and implementation of

New Delhi Quality to Sept.2005 Quality Systems as per regulated

Assurance markets (US & Europe),

Validations, Quality Trainings,

Quality Audits,

Documentations, Vendors

Approvals, Third Party

Approvals. Release of Finished

Goods for commercial sale.

Norbrook Manager, April 2003 In charge of Quality Assurance,

Laboratories Ltd. QA to February Quality Control, Microbiology

Northern Ireland, 2004 Lab. Analysis, Release of Raw

UK Materials/ Packaging Materials,

In process Materials and Finished

Goods. Authorisation of SOPs,

Validation Protocols, Change

Controls, Batch Manufacturing

and Packaging Records.

Handling of Market Complaints.

Co-ordination of Regulatory

(US-FDA, MHRA etc.),

Customers and Internal Audits.

Total Manpower Reporting to

QA, Manager about 80.

Panacea Biotec Ltd., Dy. April 2001 Creation and implementation of

New Delhi General to Oct, 2002 Quality Systems as per regulated

Manager – markets, Validations, Quality

Quality Trainings, Quality Audits,

Assurance Documentations, Vendors

Approvals, Third Party

Nov., 2002 Approvals. In April,2002 the

GM - QA to April company got very good remarks

2003 on quality systems,

documentation, validation,GMP

training etc from WHO Geneva

authorities.

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SmithKline Implementation of Quality

Beecham Manager- Sept. 1998 Systems as per World-wide

Regulatory Compliance of SB’s

Pharmaceuticals Quality to March

India Ltd., Assurance 2001 global quality policy. Quality

Bangalore,India System of ISO 9002.Approval

& control of all Quality

documents. Internal and external

Quality audits. Validation of

Machines & process. Quality

Training.

Cheminor Drugs Quality System as per US-FDA

Ltd.(Pharma Div.) Manager- April 1998 Requirements, approval and

Dr.Reddy’s group Quality to control of all quality documents.

Hyderabad,India Assurance August Facilitator of US-FDA,MCC &

1998 Internal audits. Also ISO-9001

documentation and system

implementation

Quality Control of Drug

Manager- Oct.1996 to Products, Drug Substances and

Quality March 1998 Packaging Materials as per US-

Control FDA requirements. Preparation

& Approval of Specifications,

Test Methods and Sops. Quality

Control of Drug Products, Drug

Substances and

Packaging Materials as per US-

FDA requirements. Preparation

& Approval of Specifications,

Test Methods and Sops

Dolphine Quality Standards fixation and

Laboratiries Ltd. Manager- July 1994 to Quality Control of raw materials,

Calcutta, India Quality Sept. 1996 packing materials and finished

Assurance products. In-process quality

control operations. Quality

education and quality audit.

Implementation of cGMP &

GLP aspects. Stability studies &

Analytical developments. Export

Documentation. During this

period I got trained by M/s P.E.

BATALAS of UK on the ISO-

9002 documentation system,

prepared Quality Assurance

Procedures and also obtained

Internal Auditor Certificate.

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Panacea Biotec Ltd. Total Quality Control

New Delhi, India Manager- Dec.,1991 operations; including analytical

Quality to and formulations development

Control June 1994 works,Updation of QA systems,

initiation of QA techniques,

compliance with FDA and other

regulatory authorities. Quality

education & quality audit.

Implementation of cGMP &

GLP aspects. Preparation of

export dossiers.

Sarabhai Chemicals In charge of total Stability studies

(Ambalal Sarabhai Assistant Jan.,1990 to of new & old products.

Enterprises) Manager- Nov.,1991 Development of analytical

Baroda, India Quality methods & specifications. Study

Control of market complaints,

preparation of dossiers.

Laboratory used the

modern analytical techniques viz.

Executive HPLC;GC;IR;NMR etc.

Trainee During this period I got

conversant with the various dept

viz.Formulation & Packaging

Development; Production; QC;

Engg.services;Marketing;

Purchase ;Costing etc. of

Sarabhai Chemicals and other

units of the corporate.

SCIENTIFIC PUBLICATIONS :

1) Natural Products and Plants as Liver Protecting Drugs. Fitoterapia; Vol.LVII; No.5; Page 307-

351; 1986.

2) Antihepatotoxic Activity of some Indian Herbal Formulatio ns as compared to Silymarin.

Fitoterapia; Vol.LXII; No.3; Page 229-235; 1991.

3) Antihepatotoxic Activity of Boerhaavia diffusa. Indian Drugs; Vol.27; No.3; Page 161-166;

1989.

4) Antihepatotoxic Investigation on Boerhaavia repanda. Indian Drugs.Vol.27; No.1 Page 19-

24; 1989.

5) Indian Plant Drugs of Controversial Identity. Punjab Univ. Res. Bull.; Vol.40; Parts III-IV; Page

157-177; 1989.

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6) Plant Drugs Affecting Cardiovascular System (A Bibliographic Study). The Pharmacos; Vol.28;

Page 79-102; 315 Refs.; 1989.

7) Laboratory Control-A Perspective. Pharma Times. May 1993;Page 11-13.

8) Uniformity of Weight of Coated Tablets.Pharma Times.April 1993;Page7.

MEMBERSHIP

Life member Indian Pharmaceutical Association

Associate member of American Pharmaceutical Association

Member ISPE

LECTURES

1) Significance and Techniques of Quality Assurance & Quality Control, at NIPER (National

Institute of Pharmaceutical Education & Research), Mohali, Punjab, India, 2002,2004 & 2005.

2) Validation of Facility and Equipment at NIPER, Mohali, Punjab, India, 2004 & 2005.

3) Significance and Techniques of Quality Assurance & Quality Control, at Guru Jambeshwar

University, Hissar, Haryana, India, 2002.

GMP Documentation, at NIPER, Mohali, Punjab, India, May 2005.

Essentials of Quality Assurance and Quality Management in Pharmaceutical Industry, at

NIPER, Mohali, Punjab, India, May 2005, 2007.

6) Essentials of Quality Assurance and Quality Management in Pharmaceutical Industry, at India

Habitat Centre, New Delhi in the Workshop titled ‘ GMP and Regulatory” conducted by Indian

Pharmaceutical Association, Delhi branch. Oct.2007.

PROJECT GUIDE

1) A student of IGNOU on the project titled “ Assuring Product Quality and Consumer Satisfaction

Through Good Manufacturing Practices In a Pharmaceutical Company’’

Expert Committee Member for Indian Pharmacopoeia 2007

Examiner for Delhi University for M.Pharm in Quality Assurance

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