Quality Assurance Analytical Development
Resume:
DR. BINAYA DAS,
(PhD in Pharmacy)
*************@*****.*** +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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