1. Resume Swapnil Kalwatkar
9963694601
Page 1 of 6
Objective:-
 To focus my energies and experience to enhance scientific and business aspects of the
organization.
 Exploiting my knowledge and my more than 13 years of experience, to contribute for
better efficiency, prosperity of the organization and betterment of mankind and
improving quality of life.
Qualification:-
Degree Year University Percentage /CGPA
Executive MBA
(Pharma
Management)
2008-2011 NMIMS Mumbai
(Narsee Munjee Institute of
Management Study Mumbai)
B+
M.Pharm
(Pharmaceutical
Biotechnology)
2003 -2005 J.S.S. college of Pharmacy
Ooty.
Dr.M.G.R. Medical University
Chennai
72%
Post Graduate
Diploma in Pharma
and Biotech
Regulatory Affairs
2006-2007 Bioinformatics Institute Of
India
66%
Job Profile – Manager -QA Validation
Company Year Job Description
Indian
Immunologicals
Limited (IIL)
Manager
Validation and
Calibration
March
2013 till
date
 Validation and calibration in-charge for the three units ,
Gachibowli, Karkaptla and Ooty units of IIL.
 Responsible for the calibration and validation compliance at
three IIL units which include equipment , area, utilities , media
fill , cleaning validation , process validation, new facility
qualification.
 Successfully completed qualification of Greenfield project
two formulations and filling facility which includes equipment,
area, utility and process validation.
 Successfully completed qualification of multi product 8000
L cell culture and virus culture BSL-III facility with DCS
system.
 PLC validation for the process equipment.
 SAP PR module up gradation validation with new server.

2. Resume Swapnil Kalwatkar
9963694601
Page 2 of 6
 Cleaning validation of the biological and pharmaceutical
products.
 Risk assessment of the validation and process activities for
better control ,confidence and compliance of process.
 Process validation of antigen, formulation and filling of
biological product.
 Qualification of packing line including 2D and 1D bar code
with unique global tread identification number (GTIN) as per
DGFT and GS1 guidelines.
 Team member of the implementation of track and trace
parent child relationship for the primary to tertiary packing.
 Cold chain validation and compliance.
 Regulatory audits and compliance.
 Responsible for quality management system related to
facilities and equipment.
 Team handling – 6 employees 5 –contract employee
 Successfully faced below regulatory and third party audits
 MOH Egypt
 MOH Turkey
 Sanofi merial
 Wockhardt
 Reliance life sciences
 MOH Nigeria
 MOH Iran
Dr. Reddy’s
Lab.
(Biologics
Development
Center)
Assistant Manager
QA-Validation
2007 till
March
2013

 Involve in Facility validation, utility validation , equipment
validation and transport validation
 Thermal Validation i.e. Autoclave, Tunnel, DHS, Blast freezer,
Lyophilizer, stability chambers etc.
 Aseptic media fill validation , filling line qualification
 Building management system (BMS) qualification.
 Validation protocol and report writing
 Qualified of three Greenfield cell culture Facilities
 Qualification of the Aseptic filling facility after modification .
 Validation master plan (VMP), facility validation master plan
(FVMP) and qualification protocol writing.

3. Resume Swapnil Kalwatkar
9963694601
Page 3 of 6
 Working with PM group for new Filling facility from
conceptualization stage, development of User requirement
specification (URS), Feed report.
 Developed documentation section as per ICH requirement.
 Handle Change control and deviation control system for
biological manufacturing facility as subject matter expert
(SME).
 Investigation of discrepancy and corrective and preventive
action (CAPA) implementation team member.
 Process validation of biopharmaceutical formulation, Pre-
filling syringe (PFS) product, liquid filling product and
lyophilized product.
 Third party technology transfer for aseptic vial filling operation
 Vendor Qualification for Engineering services
 Quality management system (QMS) for Engineering
and Facilities as a Facility Assurance.
 Clean utilities testing compliance for pure steam,
compressed air, N2 at set frequency.
 Classified Area viable / nonviable trend analysis.
 Water trend analysis.
 Cold chain management and transport validation.
 Cold chain vendor selection and Qualification.
 Worked on cold chain development and management for
Brazil, Peru, and Chile; addressed transit temperature excursion
complaints.
 Developed in house Frozen Drug substance cold chain pack to
maintain -20⁰C for 5 days
 Working with PM group for Greenfield cell culture
manufacturing facility with 1000 L fermenter.
 Facility validation master plan, CTP , MC ,IQ, OQ ,
protocols review and approval
 System level impact assessment (SLIA), functional
level impact assessment (FLIA), component level
impact assessment (CLIA) review approval.
 PQ protocol & report review and approval.
 Team member for the designing of liquid filling,
lyophilized product and PFS facility with PM group
Ireland.

4. Resume Swapnil Kalwatkar
9963694601
Page 4 of 6
 Successfully faced regulatory audit like-
 ANVISA
 ANMAT
 ANVIMA
 MOH Iran /Ukraine
 EU-QP-Audit
 Alliance audit-GSK
 DCGI, CDSCO
 ISO audit for QMS
Factory
Acceptance
Test
Oct-2010  Team member Factory acceptance test for Autoclave
Fedegari SpA Italy.Team member Process vessel FAT.
Wockardt
Biotech Park
Waluj
2005 to
2007
 Worked as Production Executive
 Responsible for Expanded bed chromatography (Ion
exchange chromatography )
 BPR review
 IPQC testing by HPLC , UV spectroscopy, LOD
analyzer.
Drug testing
Laboratory
(CADRACT)
Ooty.
2003
to 2005
 Microbial analysis of drinking water.
 Microbial limit tests for tablet, capsules and liquid
orals.
 Microbiological Assays for Vitamins and Antibiotics
 Sterility testing
Dissertation/Projectwork:-
Degree Year Scope of Study
MBA 2010-2011 Title:-Strategy to commercilization of Biosimilar in European
Union.
PGD-
DRA
2005-2006 Drug Masterfile preparation and Maintanace as per CTD
modules
M.Pharma 2004-2005 Production, Optimization and Screening of Antibiotic Produced
by Aspergillus nidulance for Antimicrobial and anticancer
properties.

5. Resume Swapnil Kalwatkar
9963694601
Page 5 of 6
Training attended:-
Seminar /cGMP training Year Trainer
Validation and Regulatory
issue for biopharmaceuticals
2008 Mrs.Gail Sofer
GE fast track training and
education
Thermal validation 2010 GE Skytech services
QMS 2011 CK Murthy
Auditing techniques 2011 Ivy Louis IVN consultancy
C & Q approach for new and
renovated facilities
2011 Mr.Dereck PMCRB
Achievements and awards within organization:-
 Appreciation award for the successful facility validation year 2008.
 Appreciation award for cold chain system development year 2009.
 Certified auditor by external agency Ivy Pharma consultancy.
PosterPresentedin Nationaland International Symposium:-
 Published a Paper in INDIAN JOURNAL OF PHARMACEUTICAL EDUCATION
(IJPE, JULY – SEPTEMBER 2000) under section Laboratory Innovation.
 S.A. Dhanaraj, P. Vijayan, Samir Phulari, K. Swapnil, Yadav Vivek and
B.Suresh.Free radical scavenging studies of Grewia tiliaefolia. Scientific poster
presentations, 55th IPC 2003, Chennai.
 Swapnil, Preetima M.S., S.A.Dhanaraj, P.Vijayan, C. Raghu, B.Suresh. In vivo and in
vitro anti-tumour study of antibiotic produced by Aspergillus nidulance ASP-6 by
using DLA cell line. ICHS-Poster presentations-2005, Mysore
 S.A.Dhanaraj, P.Vijayan, C. Raghu, Swapnil Kalwatkar, Parag. S. Kularni and
B.Suresh. Production, Optimization and Screening of Antibiotic produced by
Aspergillus nidulance for Antimicrobial and Cytotoxicity activity. ICHS-Poster
presentations-2005, Mysore
Scholarships Awarded:-
 Talent Search Scholarship in 7th standard.
 Open Merit Scholarship in 10th standard.
 Tamilnadu Pharmaceutical Science Welfare Trust Scholarship for Project
Work carried out in 2nd Year of M. PHARM.
PersonnelDossier:-
Name : Swapnil
Father’s Name : Shankarrao Kalwatkar

6. Resume Swapnil Kalwatkar
9963694601
Page 6 of 6
Date of Birth : 15-06-1979
Marital Status : Married
Language known : English, Hindi and Marathi
Present Address : Swapnil S. Kalwatkar
Janapriya Nile Valley
flat no 1209 block-1C
Madhavpuri Hills
Madinaguda Hyderabad
Email Address : swapnilkalwatkar@gmail.com
swapnil_kalwatkar@rediffmail.com
Phone Number : 9963694601,
9951477706
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