The document provides details about Shivbachan Singh Kushwaha's professional experience and qualifications. He has over 24 years of experience in quality and operations management, research and development, and production planning. Currently he works as Quality Manager at Johnson & Johnson India Ltd., overseeing quality assurance and management systems. Previously he has worked in leadership roles at E.I. Dupont India, Monsanto Research Centre, and other companies. He has extensive experience implementing quality standards and systems.

1. SHIVBACHAN SINGH KUSHWAHA
RH # W-2, Shinde Windflower, Gut # 158, Satara Parisar, Beedbypass ,Renukamata Mandir Road, Aurangabad-431005, India
T +91 – 8806664427; E -shivbachansingh@gmail.com / skushwah@its.jnj.com
Quality and Operations Management ~ Research & Development ~ Production Planning
& Control ~ Quality & Compliance
Offering 24+ years of experience
PROFILE
 Proactive professional with proven ability to streamline production, quality
assurance, research & development, new product development
functions to optimize operational efficiency. Strong background in
judiciously deploying plant resources - Manpower, Materials and Machines
to maximize capacity utilization and achieve profitability milestones.
 Fully conversant with Statutory & Regulatory requirements for
uninterrupted site operation and Product Quality Standards. Deft in leading
mass movements involving hundreds of direct and indirect employees to
significantly enhance Quality Standards of products, supply chain and
distribution.
 Demonstrated strengths in implementing and improving Quality standards
and norms. Proficient in modern manufacturing management and quality
systems such as HACCP, TPM, ISO, etc.
 Expertise in conducting Quality Audits and evaluating internal control
systems to ensure adherence to stringent quality standards; identify
shortcomings and recommend need based solutions.
 Seasoned professional, with planning, implementation, monitoring and
resource balancing skills and ability to handle multiple functions in high
pressure environments.
 Suave and pragmatic with excellent interpersonal and communication skills,
competent to work in highly diverse environments with people from varied
backgrounds. Keen planner and farsighted with strengths to perceive beyond
obvious. Result driven and focused with immaculate work habits, excellent man-
management, time management and leadership skills
WORK EXPERIENCE
Official Visits Israel, USA, Netherland, Switzerland & Belgium
Audit Handled: In-house: IA, ERC, JJRC and MOCK USA FDA
External: SGS (OSHA 18001), Bureau Veritas (ISO 9000:2008 and BIO ETS), BSI (ISO13485), Local
FDA and WHO GMP

2. Responsibilities Handled
• Spearheading efforts as a QA Manger for Aurangabad Site and accountable for oversight and execution of Quality Management
Systems(as per ISO 13485, ISO 9001, Schedule M-III, WHO) at Aurangabad site that manufacture sutures and delivers
finished goods to distribution centers.
• Planning, coordinating, and directing quality assurance programs designed to ensure effective and consistent processes with
established standards by performing the duties personally or through subordinates
• Accountable for handling Special Processes like QA controlled document issuance, batch Card Review and Batch release
authorization and also Stability study program.
• Handling the product Complaint Management and Product Recall Processes. Responsible for overseeing the controls and
quality standards for Quality systems validation, including, Cal/PM, CAPA, NC, IA, Doc mgmt. software systems
• Responsible for ensuring the quality of incoming raw and packaging materials, process control activities, specially to minimize
deviations thereby helping to reduce material usage variances
• Responsible for regulatory submissions, managing relationships within the relevant regulatory agencies, assuring all
regulatory submissions are accurate and submitted in a timely manner and understanding the impact of any pending or
proposed regulatory changes
• Responsible for assurance of supplies through supplier audits and feedbacks.
• Aligned QA function vision with the Company goals, leading the team for achieving the objectives and built alliance to support
other functions and overall business
• Accountable for management of Quality systems, document management, change control, Risk Management and record
management.
• Accountable for review and approval of quality documents in document management system.
• Responsible and accountable for Quality Operations department yearly business financial planning, capital, quality system and
product process projects.
• Carrying out managerial responsibilities in accordance with the organization's policies and applicable laws; including,
interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; addressing
complaints; and, resolving problems.
Other Responsibilities Handled in the Past
• NCR Site Lead- Facilitate the NCR Process at the site, Authorize and perform invalidation of NCRs, as applicable, Perform
site/area Nonconformance data analysis, Present data analysis to the CRB as appropriate, submit data for Management Review,
Ensure training of all NCR users, Review and approval of NCR and PCR files and Stop Shipment Process Owner
• CAPA Site Lead- Facilitate the CAPA Process at the site, Originate CAPA’s in the CAPA Application, Facilitate the CAPA Review
Board and maintain objective evidence of the review, Void CAPA’s, Submit data for Management Review, Assure all CAPA Owners,
CAPA Activity Owner, Approvers, and CAPA Review Board members are trained, Assure that data analyses from quality sub-
systems are documented and retrievable, Analyze CAPA data and Facilitate the identification of management CAPA’s
Johnson & Jonson
India Ltd. | Since
July 2011
Manager
Quality
Assurance
Reporting to:
Plant Quality
Manager
No. of
Employees
reporting: 8 (5
direct, 3
indirect)
E.I. Dupont India
Pvt. Ltd. | January
2009-Jun 2011
Greenhouse
Operations
Manager
Reported to:
Trait
Characterizati
on and
Development
Lead
No. of
Employees
reporting: 4
Monsanto
Research Centre,
Bangalore |
February 1999 –
December 2008
Plant Growth
Resource
Management
Lead
Reported to:
Functional
Head
No. of
Employees
reporting: 6
Micro Plantae Ltd.,
Pune / Mumbai |
September 1996 –
February 1999
Sr. Production
Executive
Reported to:
Managing
Director
No. of
Employees
reporting: 4
Irrigations and
Systems Ltd.,
Maharashtra |
March 1995 –
September 1996
Production
Executive
Reported to:
Departmental
Head
No. of
Employees
reporting: 5
Glaxo India Ltd.,
Maharashtra |
April 1991 – July
1993
Quality
Assurance
Microbiologist
Reported to:
Section Head

3. • External Assessments - Scheduling supplier audits and sending out of Desktop Audits, Review of audit reports and follow up with
auditor as necessary on audit report clarity, Update Supplier Quality Audit procedures in local document management system,
Review of supplier submitted corrective action plans and objective evidence, Provide site guidance on supplier audit program
requirements and supplier compliance, Work with SQM and suppliers to provide guidance in the closure of observations.
• Training – Preparation and submission of QA training matrix and training schedule to HR, Ensuring completion of training as per
the schedule, training the NCR & CAPA users on applicable procedures.
• Monthly and Biweekly Quality data reviews meetings – conducting monthly and biweekly quality data reviews with metric owners
at the site and ensuring appropriate corrective and preventive actions are in place.
• Document Management System- Established the Pharmadoc document management process at the site for control of documents.
Ensuring periodic revision of control documents.
• Internal Audit – preparation of audit schedule and audit plan, conducting audit of various processes and departments,
preparation of audit report, audit observations failure investigations, implementation of corrective and preventive actions a s per
plan and audit closure.

4. •Deployed successfully ADAPTIV Change management and Document management system at India Sites
•Deployed successfully ETQ Application for CAPA Process at the site
•Established Pharmadoc document management process for control of documents
•ISO 9000:2008 and BIO ETS – certification of Controlled Environment Facility
•Established greenhouse protocols and processes for conducting research.
•Delivered glyphosate resistance (Roundup Ready) lead lines for ornamental plants- petunia and marigold
•Contributed, significantly, in discovery of stress tolerance gene leads
•Completed successfully transgenic research projects across ornamental plant (petunia and marigold), Rice
Functional Genomic, Beta carotene in Indian Mustard and Characterizing Gene Expression Elements in corn and
soybean
•Global Monsanto Technology “Above and Beyond” award (2004) for significant contribution in “Proof of Concept”
for drought tolerance gene in rice model system
•Trait development in transgenic crops Gene expression analysis, Greenhouse technology and automations,
Knowledge management, Bio-safety management, Clean room management
•Successfully adapted and implemented screening procedures for segregating population of transgenic corn,
soybean, rice, and ornamental plants
•Improved grain yield (seed numbers) in a corn inbred line that was critical for the success of expression elements
characterization project.
•Introduced the concept of Qualitative Gus Analysis of corn transgenic events at R0 generation for early IP value
capture. Today this concept has taken a shape of mega project to screen large number of expression elements.
•Trait integration for production of corn hybrid seed to study interaction of genotype and promoters
•Implemented greenhouse automation system and automated data capture mechanism using two dimensional
barcode systems.
•Discovered a method of corn seed chipping at 3-DAG (three days after germination) stage for early detection of
Gus active transgenic events / plants and molecular analysis.
PROFESSIONAL ACHIEVEMENTS:
•One Encore Award -2015(Platinum) for deployment of ADAPTIV Change Management and Doc Management
system to Ethicon India sites.
•One Encore Award -2014(Gold) for Demonstrating Connect & Shape leadership Imperatives in conducting product
Risk assessment documentations in response to facility assessment.
•Four Encore Awards-2012 (Gold and Platinum) for supporting ERC audit, RLP program and developing controlled
documents at Vision Care Warehouse.
•Monsanto Research Centre (MRC) Distinction Award 2000 (Man of the Year award - 2000)-for outstanding
contribution in trait development for Smart Plants
•Global Safety and Health Award 2001-Made significant contribution as ESH team member that enabled MRC to
secure Global Safety and Health Award 2001
•Rapid Recognition Award (2003) for contribution to Project - Improved Stress Tolerance in Crops that was
nominated for Pledge Award under Benefits Category.
•Crop Transformation and Functional Genomic (CTFG) Special Recognition Award (2003) - for valuable contribution
to Promoter characterization project by increase higher seed set in corn H99 genotype.
•Special Recognition Award (2003) - for valuable contribution made as a Member of ESH Team that secured OHSAS
18001
•Global Monsanto Technology “Above and Beyond” award (2004) for significant contribution in “Proof of Concept”
for drought tolerance gene in rice model system.
•MRC Rapid Recognition Award (2007) for “production and identification of Marker Free Transgenic Corn plants”.
AWARDS & ACCOMPLISHMENTS:

5. ACADEMIA
 MBA in Operations Management; ICFAI, Hyderabad
 Master of Technology (Applied Botany, Biotechnology); IIT Kharagpur, West Bengal with a CGPA of 8.17 out of 10
 Diploma in Pharmaceutical Quality Control and Quality Assurance Management; Institute of Pharmaceutical Education and
Research (IPER), Pune; Distinction
 Master Degree in Science (Microbiology); Mumbai University, Mumbai, Second Class
 Bachelor Degree in Science (Microbiology); Mumbai University, Mumbai with a First Class
PERSONAL DOSSIER
Date of Birth: 17th January 1966
Languages Known: English, Hindi & Marathi
Passport No: J1247687; valid till:31st October 2020
Notes: Pls Refer the Annexure
References: Available on Request
Trainings & Seminars Attended:
ISO13485,Project Management, Six Sigma (Green
Belt), GMP, GLP, Safety, Hygiene, Greenhouse
Technology, Team Building, Self-Awareness,
Communication and presentation skills, People
management and People Leader Learning Series
Attended and presented posters in more than 10 in-
house, national and international seminars,
workshops and symposia
Publications/Patents:
Contributed significantly towards the claim of more
than dozens patents.
N.Shiva Prakash , R. Bhojaraja, S. K. Shivbachan , G.
G. Hari Priya, T. K. Nagraj, V. Prasad , Srikanth Babu,
T. L. Jayaprakash, Santanu Dasgupta T. Michael
Spencer, Raghava S. Boddupalli,(2009), Marker-free
transgenic corn plant production through co-
bombardment. Plant Cell Report

6. ANNEXURE
PROJECTS HANDLED
SOFTWARE APPLICATIONS HANDLED
Software
Application
Description Year Organization
Virgo Greenhouse and Field Experimental process & data
management system
2001-
2006
Monsanto
Saturn Plant Transformation and greenhouse and fields process &
data management system
2007-
2008
Monsanto
Documentum Document Management system 2007-
2008
Monsanto
PLM Matrix NCR and CAPA process Management System 2011-
2013
Johnson &
Johnson(JNJ)
Pharmadoc system Document Management system 2012-
2015
Johnson & Johnson
ETQ Application NC, CAPA and Audit process management 2013 Johnson & Johnson
Siebel Customer product Complaint Management System 2013-till
date
Johnson & Johnson
Instantis Project Management 2014 – till
date
Johnson & Johnson
ADAPTIV Document Management system 2015 Johnson & Johnson
MiniTab Data Analysis tool 2005 Monsanto, Dupont &
JNJ
Johnson & Jonson Pvt. Ltd. | 2011 -
2015
•Deployment of ADAPTIV Change
management and Doc management
system at India sites
•Transfer of Complaint Handling unit
to Business Quality
•Deployment of ETQ Application for
CAPA Process at Aurangabad
•Deployment of Ongoing stability
study of Ethicon Products at India
sites
•Conducting Mock product Recall
•Deployment of Pharmadoc
Document Management system to
Ethicon and ASP India sites
E.I. Dupont India Ltd | 2009 – 2010
•Controlled Environment(CE)
Facility - Establishing and validating
6000 square feet CE facility for
transgenic research
•ISO 9000:2008 and BIO ETS –
Certification of CE Facility
•Establishment of germplasm
storage(at 10 degree centigrade)
facility
•Tracking plants and germ plasm
inventory using barcode system
Monsanto | 1999- 2005
•Deployment of data Capture
mechanism using 2D barcode
system
•Beta Carotene-Developing
transgenic trait in Indian Mustard
•Characterizing Gene Expression
Elements
•Controlled Environment(CE)
Facility - Establishing and validating
2500 square feet CE facility for
transgenic research
•Functional Genomic - Validating
gene functions
•Smart Plant-Developing transgenic
trait in Ornamental plants