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DR. BINAYA DAS,

(PhD in Pharmacy)

ad4gyd@r.postjobfree.com +91-774*******

QUALITY ASSURANCE

EXECUITVE PROFILE:

Achievement and Performance driven professional with more than 24.6 years of experience in Quality Assurance (cGMP, GCP and GLP compliance). Experienced in Implementation of Integrated Quality Management System in Corporate Quality Assurance

Handled Various QMS and its trend evaluation on periodic basis to identify lead and lag indicators

Experienced in full investigation of any product failure w.r.t. Deviation, market complaint, product recall, batch failure, bio-study failure etc. Experienced in both facility-based auditing and project-based auditing and compliance of manufacturing unit, R&D, pharmacovigilance, BA/BE centre, CMO, CTL and CRO Experienced in handling of Development QA in R&D, Analytical Development team with various dosage unit

Experience in Quality Control, Analytical Development and Bioequivalence study Piloting Quality Assurance team, Analytical Development team, CRO team. Experienced in handling Quality Assurance of Solid / Liquid Oral, Parenteral, Ophthalmic, Nasal, MDI, DPI product manufacturing unit. Experienced in handling of Development QA, Analytical Development team with various dosage unit

Experienced in implementation and overall management of CRO Successfully cleared Regulatory Audits conducted by USFDA, MHRA, TGA, WHO GENEVA and ANVISA

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PROFESSIONAL SKILLS

Department Professional Skills

Quality Assurance 1. Implementation of Integrated QMS throughout the all branches of Pharma company

2. Implementation of all department SOPs for cGMP

manufacturing as well as R&D

3. Implementation of all quality documents throughout pharmaceutical industry

4. Internal Auditing and compliance as per cGMP,

GLP and GCP

5. Third party audit and compliance

6. Execution of all Equipment Qualification

7. Execution of Water System Validation

8. Execution of HVAC System

9. Vendor Qualification

10. Handling of Change control, Deviation, Investigation and Compliance

11. Make the company 24/7 Inspection readiness

12. Training Management

Quality Control 1. Experiences in Testing of raw material and finished product for various dosage form

2. Experiences in Instrument operation

3. Implementation of all procedural and instrumental SOPs, STPs, GTPS, protocol and report in QC

4. Method verification and Method validation

5. Instrument Qualification and calibration

6. Evaluation of API and excipient vendor

7. Overall Management of all QC staff and laboratory 8. Microbiology Assay, Sterility and Bacterial

Endotoxin Test

9. Environmental monitoring

Analytical Development 1. Overall management of Analytical Development lab 2. Method Development

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Department Professional Skills

3. Analytical Technology Transfer

4. All analytical SOPs, STP, GTP, Protocol and Report 5. Finalization of Specifications

6. Evaluation and justification of Impurities

specification

7. Residual solvent, Nitrosamine and Elementary

impurities evaluation

8. Vendor Qualification

Clinical Research

Organization

1. Overall management of Bioequivalence study

2. Clinical:

2.1 Protocol Designing and execution of all clinical activities

2.2 Volunteers Management

2.3 RLD Management

2.4 Equipment and Instrument Management

2.5 Clinical Study Report

2.6 SOPs and other Quality documents

implementation

3. Bioanalytical:

3.1 Instrument Qualification and calibration

3.2 SOPs and other Quality documents

implementation

3.3 Method Development and Method Validation

3.4 Subject Sample analysis

3.5 Bioanalytical report

4. Biostatistics:

4.1 Experiences in SAS Software

4.2 Sample size calculation

4.3 Randomization

4.4 Pharmacokinetic (PK) analysis

4.5 Statistical analysis

4.6 Interpretation of Pilot study data for Pivotal success

4.7 Statistical report

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Department Professional Skills

4.8 SOPs and other Quality documents

implementation

5. Diagnostic / Pathology Lab:

5.1 Implementation of Diagnostic lab set up used for BA/BE study

5.2 Implementation of all SOPs and logbooks

5.3 Overall management diagnostic lab

6. Quality Assurance

6.1 Overall management of QMS

Pharmacovigilance 1. Implementation of QMS

2. Implementation of SOPs and required Quality

Documents

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CAREER TIMELINE

Sr.

No.

Organization Name Last

Designation

Year No. of

Years

Promotion

1 Kenpack

Pharmaceuticals Ltd.,

Mumbai, India / Axar

Pharmaceuticals, Inc.,

USA ( TAP

Pharmaceuticals AG,

Switzerland) (A Famy

group).

GM-

Quality

Assurance

October 2021

to till date

1 Year 7

Months

as on 5th

May 2023

--

2 Beximco

Pharmaceuticals

Limited, Dhaka

Head

Analytical

December

2014 to April

2021

6 Years 4

Months

Joined as Expat.

Initially joined as

DGM-Quality,

then Head

Analytical and

additionally

appointed as Head

CRO for Novus

Novus Clinical

Research Services Ltd,

Dhaka

Head CRO

3 Alkem Laboratories

Limited, Navi Mumbai,

India

Assistant

General

Manager-

QA

September

2007 to

October 2014

7 Years Three (3)

Promotion.

Manager, Sr.

Manager and

Asst. General

Manager

4 Macleods

Pharmaceuticals

Limited (Both Plant-

Daman, Gujrat and

R&D-Andheri,

Mumbai), India

Manager-

QA

August 2003

to September

2007

4 Years 1

Month

Four (4)

Promotion.

Executive,

Sr. Executive,

Asst. Manager

and Manager

5 Orchid Healthcare (Part of

Orchid Chemicals &

Pharmaceuticals Limited),

Chennai. India

Executive-

Microbiolo

gy

March 2002 to

July 2003

1 Year 4

Month

No Promotion

6 Troikaa Pharmaceuticals

Limited, Ahmedabad, India

Chemist -

QC

August 1999 to

March 2002

2 Years 7

Months

No Promotion

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JOB RESPONSIBILITY

Sr.

No.

Organization Name Job Responsibilities

1 Kenpack Pharmaceuticals Ltd.,

Mumbai, India / Axar

Pharmaceuticals, Inc., USA ( TAP

Pharmaceuticals AG, Switzerland)

(A Famy group).

Head of Quality Assurance in both India and

USA projects

Additional responsibility of Clinical activities for 505j and 505b2 submission

Auditing and compliance of CMO, CRO and

CTL

2 Beximco Pharmaceuticals

Limited, Dhaka

Overall management and Heading of

Development Quality Assurance System in

R&D with 10 subordinates

Overall management and Heading of

Analytical Development Laboratories in R&D

with 80 to 90 subordinates

Planning and Execution of Department’s

activities

Quality system in Pharmacovigilance

Training

Outsourced Bioequivalence study

Novus Clinical Research Services

Ltd, Dhaka

Overall management and Heading of CRP

with 25 subordinates

Planning and Execution of Department’s

activities

Training

3 Alkem Laboratories Limited, Navi

Mumbai, India

Head of Quality Assurance System in

Bioequivalence with 10 subordinates

Implementation of all quality documents

across the centre

Additional activities as Corporate Quality

Assurance

4 Macleods Pharmaceuticals

Limited (Both Plant-Daman,

Gujrat and R&D-Andheri,

Mumbai), India

In Daman plant, IPQC activities, SOP

preparation, execution and training, all

quality documentation, equipment

qualification, Water system and HVAC

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Sr.

No.

Organization Name Job Responsibilities

system and other utility validation, process

and cleaning validation.

In R&D, Head of Quality Assurance System

in Bioequivalence centre with 10 subordinates

Implementation of all quality documents

across the centre

Vendor qualification

DQA activities

5 Orchid Healthcare (Part of Orchid

Chemicals & Pharmaceuticals Limited),

Alathur, Chennai. India

Responsibility for Microbiology department

the centre

Preparing all Microbiology related all SOPs

and other documents

Microbiology assay testing, sterility testing,

endotoxin testing, preservative efficacy,

environment control

Equipment Qualification

Area Qualification

6 Troikaa Pharmaceuticals Limited, Thol,

Ahmedabad, India

Chemical Analysis as well as Microbiological

analysis of raw materials and finished

products

Environmental Monitoring

PROJECTS SUBMITTED

Bioequivalence study of Lansoprazole during my M. Pharm, from SVKM’s NMIMS, Vile Parle, Mumbai, India

Bioequivalence study of Gabapentin during my PhD in Pharmacy, from JJT University, Rajasthan, India

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APPROVAL

FDA approval on Physico and Chemical testing (Gandhinagar, India)

FDA approval on Microbiology and sterility testing (Gandhinagar, India) PUBLICATION

Bioequivalence study of Gabapentin, IJPI, 2013

EDUCATION

Doctorate of Philosophy (PhD) in Pharmacy from JJT University, Rajasthan, India

Master in Pharmaceutics (M. Pharm) from SVKM’s NMIMS, Vile Parle, Mumbai, India

Bachler in Pharmacy (B. Pharm) from SIPS College, Utkal University, Bhubaneswar, India Additional Course:

SAS Training, SAS India

Diploma in Business Management from All India Institute of Management Studies, Chennai PERSONAL DETAILS

Date of Birth : 5th March, 1975

Father : Mr. Bimal Krushna Das (Ex-Serviceman and Ex-LIC)

Mother : Mrs. Binapani Das (House Wife)

Wife : Mrs. Arpita Das (House Wife)

Elder Son : Master Tejash Das (Student)

Younger Son : Master Dharmik Das (Student)

Contact Address : AT/PO: Kantapari, Thana: Dhamnagar, Dist: Bhadrak, State: Odisha, India-755006

Languages Known: Odiya, Hindi and English

DECLARATION:

I hereby declare that the information furnished above is genuine to the best of my knowledge. DR. BINAYA DAS

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