Vishal Rupani - Page 1 of 6

VISHAL

Summary:
• Chemical and Computer Engineer with over 15 years of experience in GMP regulated
industry and over Five years of experience in managing a Quality assurance staff.
• Good understanding of Aseptic Operations, underlying principles of Quality
Management Systems for Biologics and Biopharmaceutical products like Change
Control, Deviation, CAPA etc.,
• Experience in deliverables for computer systems/ Automation validation (LIMS, SAP
R/3, PCS, SCADA, BMS), Equipment Validation (Tanks, Autoclaves, Lyophilizers,
Vial Washing, Depyrogenation Tunnel, AHU’s, Water Systems, Bench top QC
equipment like HPLC, Freezers and Refrigerators), Process Validation (CIP, SIP,
Mixing, Media Hold studies).
• Experience in facing Customer and Regulatory Audits from regulated and semi
regulated countries. Knowledge of in-process QA function for Monoclonal Antibody’s
Cell-Culture and Purification process manufacturing. Adequate knowledge of
regulatory guidance’s from FDA, EMEA, HC, ICH, ISPE.

Education:
• Masters in Chemical Engineering, Manhattan College, NY – (May 2001- May 2003)
• Masters in Computer Engineering, Manhattan College, NY – (Aug 2000 - May 2002)
• Bachelor in Chemical Engineering, India- (June 1995 - Apr 1998)
• Diploma in Chemical Engineering, India- (Apr 1992 - Apr 1995)

Experience:

Feb 2016-Jun 2019 Intas Pharma (Biopharma Division), Ahmedabad, India

Intas is a leading, vertically integrated global pharmaceutical formulation
development, manufacturing and marketing company headquartered in India. Intas
has made a substantial commitment to its Biologics Business Unit in terms of creating
R&D, manufacturing and marketing capabilities for its biotech portfolio. As on date,
Intas commercialized 11 biologic products and continues its R&D efforts in chronic
disease areas such as oncology (cancer), rheumatology, auto-immune, nephrology,
ophthalmology and plasma derived product-based therapies.

QA Operations Deputy General Manager

• Responsible for Biological DSQA and DPQA related activity for Microbial and
Mammalian Products.
• Providing guidance to the team on compliance, FDA/international regulations.
• Facilitating Audits and ensuring SME’s are audit ready.
• Responsible for providing necessary support to Regulatory Affairs for filing (IND,
IMPD) of Clinical trial Applications.
• Attended internal CMC meetings and involved in preparation of questions for
Scientific Advice.
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• Overseeing of Training and document management system to ensure required

support for regulatory agency audits and inspections.
• Ensure the participation of relevant QA for various validation (Process Validation /
Media Fill Validation / Cleaning Validation /Facility/Utility / Equipment
Qualification etc.).
• Responsible for setting-up communication channel with business partners and adhere
their requirements as per quality agreement.
• Provide support in maintaining site Master Validation Plan and Site Master File.
• Monitor & follow up for closure of QMS related activities.
• Ensure Quality updates are provided to higher management.

Feb 2010-Jan 2016 Biocon Ltd., (BBPL-B1 Block), Bangalore, India

Biocon is India’s largest Biotech Company, headquartered in Bangalore and among
few companies in the world with a diverse scientific skill base and advanced
manufacturing capabilities for the development and commercialization of
biopharmaceuticals. They offer range of products from fermentation derived small
molecules to recombinant proteins and antibodies.

Process/Validation Quality Assurance Senior Manager

• Responsible for managing Validation Activities for Bio burden-controlled Drug
Substance and Sterile Drug Product Manufacturing Facility and Utilities.
• Involved in Start-Up of Disposable Pen Secondary Packaging facility.
• Worked with cross-functional teams for tech-transfer and scale-up of products to
supply the needs of phase-I and Phase-III Clinical Trials (MAB’s based products-CHO
cell line).
• Responsible for providing QA support in requirements for manufacturing of
Commercial products.
• Involved in GMP and due-diligence audits of Contract testing laboratories, Service
Providers and Contract manufacturers.
• Involved in developing strategy for process validation.
• Assisted in establishing Quality Assurance group’s annual goals.
• Responsible for overseeing PM and Calibration programs within the facility.
• Involved in independent review of Batch records in terms of FDA/regulatory
compliance; component added; laboratory results compared to actual lab printed
report; and completeness and accuracy of the information recorded in the Batch
Record.
• Involved in planning of mock-inspections to assess readiness.
• Introduced Product Change-Over Line Clearance and Shop Floor inspection concept
for areas and equipments within the Drug Substance manufacturing facility.
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Mar 2006-Dec 2009 Employed By- Medimmune LLC. Frederick, MD A subsidiary of

ASTRA ZENECA
Medimmune, LLC. The company is focused on the areas of infectious diseases, cancer
and inflammatory diseases. Medimmune is headquartered in Gaithersburg, Maryland
with manufacturing facilities in Pennsylvania, California, Kentucky, the United
Kingdom and the Netherlands. The company's marketed products include Synagis®
(palivizumab- NSO cell line), Ethyol® (amifostine), FluMist® (Influenza Virus Vaccine
Live, Intranasal), and CytoGam® (cytomegalovirus immune globulin intravenous
(human)), with additional products in clinical testing. MedImmune was awarded a
contract to manufacture monovalent (single-strain) live attenuated influenza vaccine
for Novel Influenza A (H1N1).

May 2005 – Mar 2006 Employed By- International Solutions Group, Herndon VA
Client: Medimmune LLC. Gaithersburg, MD A Subsidiary of ASTRA ZENECA
International Solutions Group, Inc is a consulting and IT services company that
offers a wide range of solutions to its clients. Headquartered in Herndon, VA. Over
the past ten years, International Solutions Group (ISG) has built a successful
worldwide IT Consulting business to address the full range of Enterprise customer's
and partner's needs.

SAP Validation Consultant/ Validation Engineer III/ Process Engineer III

Responsibilities:
• Performed periodic review of systems in the form of system certifications to monitor
the validation status of the system.
• Performed IOQ execution of UF/DF skid, on-line endotoxin analyzer.
• Involved in Reviewing Environmental Monitoring PQ protocol, review of cleaning
methodology, room classification
• Involved in Building start-up activities (Ex: FAT of PCS system, Commissioning of
Downstream related systems).
• Involved in Review, trend and analyze start-Up process data using Rockwell’s Factory
Talk Data Historian to ensure product quality, process performance and to
understand the process implications.
• Involved in reviewing the product safety, Deviations and Change Request related
Reports Generated from the Quality Systems.
• Involved in Temperature Mapping of Product Hold Tanks using Kaye Validator 2000.
• Reviewed Autoclave validation including cycle development and load configurations.
• Reviewed IQ/OQ documents of Tanks, Glass washers, Refrigerators, Ovens and
Freezers.
• Performed mixing validation for various Tank size.
• Worked with QA/Compliance to track and coordinate any validation change control
and/or corrective actions.
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• Validation document Review for SAP 5.0 Upgrade: User and Functional
Requirements, Software Configuration Specifications, Validation plans, Operational,
and Performance Qualifications, traceability matrixes, risk analysis, and validation
summary reports.
• Provided Business Process definition- support in the creation of Standard Operating
Procedures and work instructions.
• Responsible for overseeing of Business Process Test script review/ approval
• Engaged in driving the software validation process to assure that it is consistent and
compliant with MedImmune’s SOPs and IT good testing practices
• Worked with application administrators, management, IT staff, Computer Systems
Validation Committee (VAC), and the Computer Validation & Electronic Records
Specialist on validation issues.
• Operated online Trackwise from Sparta Systems and Plateau’s Learning Management
System for managing ongoing Training.
• Evaluated EDMS interfaces, components and tools (Doc Compliance 1.3 by Qumas) as
per the CGMP and 21 CFR part 11 guidelines.
• Validated and performed change control testing including the design/completion of
tests to challenge the software, and documenting results/installations as required by
GLPs and/or SOPs
• Reviewed IQ/OQ/PQ protocols/test scripts in accordance with SOPs for Building
Management Systems (BMS) in accordance with 21CFR Part 11 and GMP/GLP
regulations.
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Client: Ohm Laboratories Inc., NEW BRUNSWICK, NJ A subsidiary of RANBAXY

Laboratories LTD.,
Ohm Laboratories, Inc. headquartered in Princeton, NJ acquired by Ranbaxy in 1995,
manufactures prescription and Over-the-Counter (OTC) drugs in solid dose forms
(capsules and tablets) and is U.S. Drug Enforcement Agency (DEA) approved to
manufacture controlled substances. Ohm has U.S. Food and Drug Administration
(FDA) standards for facilities, products, quality systems and procedures. Facilities are
routinely inspected and approved by the FDA, the DEA and the European Union.
• As a Lead, responsible for reviewing and revising Validation efforts and deliverables
for the project.
• Performed PLC 5 based validation for Fluidized Bed Dryer.
• Involved in Validation (IQ/OQ) of Lyophilizer (verifying clean steam supply for
sterilization, operation of vacuum pump, drying chamber, ice condenser and cooling
system and qualification of automated control system.
• Responsible for creating Validation strategies, reports, Test plans and executed the test
scripts and recorded the results.
• Ensured that the system’s validation state is maintained through proper testing as part
of the change control program and re-validation as necessary.
• Implemented Alarm system, along with messaging system in stability Chamber.
• Responsible for preparing documents for CSV – Computer Systems Validation as per
the FDA regulations in accordance with 21 CFR Part 11. Wrote validation
documents/IQ/OQ/PQ test scripts and SOP in accordance with 21 CFR Part 11 and
GxP regulations and guidelines.
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Shop-Floor Trainee Engineer

• Monitored and analyzed of manufacturing data as necessary to provide support for
process discrepancies, investigations, or equipment troubleshooting.
• Verified field instrument/equipment calibrations (i.e. - electronic test equipment,
temperature, pressure, %RH, conductivity etc.).
• Completed documentation, IQ/OQ/PQ & filing as well as data entry, maintain
housekeeping
• Provided “on-the-floor” support.
• Reviewed clean room records of the facility.
• Daily recording of clean room parameters like Temperature, RH and differential
Pressure.
• Responsible for development of new equipment requirements and operating
parameters.
• Provided factory acceptance testing and validation support.
• Responsible for providing weekly status reports and progress reports to the manager.
• Reviewed Manufacturing Batch Records.

Manufacturers, Importers and exporters of pesticides/Fertilizers like Fenvalerate,

Cypermethrin, Chlorpyriphos, Alphamethrin, Permethrinm, Mpb/cmac and Diethyl
Thiophosphoryl Chloride.

R&D Chemist
Responsibilities:

• Performed bench-scale studies as well as pilot plant runs.

• Coordinated between plant operators & managers.
• Responsibilities included product development, and improvement of quality & yield.
• Performed concurrent runs throughout stages of production to determine degree of
control over variables.
• Monitored small scale and large-scale processes to identify and resolve equipment and
processing issues.
• Optimized raw material consumption.