DIPALI PATEL

235 Old Wood Lane, Kernersville, North Carolina 27284

336.499.0393
336.486.3173
prarthna76@yahoo.com

QUALIFICATIONS PROFILE
Highly motivated, talented, and performance-driven professional, offering broad-
based experience in Equipment Qualification, Process Validation, and Research an
d Development coupled with strong educational foundation. Equipped with stellar
reputation in developing innovative products from conceptualization to developme
nt, and all the way to commercialization. Adept at project-related changes and i
mprovements, with respect to applicability, quality, safety, and cost. Accustome
d to fostering positive working relationships among diverse team members to opti
mize operational efficiency and maintain safe operation at all times. Known for
keen eye for detail and extreme capability to multitask in vastly competitive, c
hallenging, and fast-paced environments.

CORE STRENGTHS
- Product Research and Development
- Project Management and Operations
- Statistical Design and Analysis
- Regulatory Compliance and Quality Assurance
- Time Management and Prioritization
- Continuous Process and Performance Improvement
- Budget Implementation and Cost Control
- Leadership, Training, and Team Building
- Articulate Oral and Written Communication
- Problem Resolution, Decision Making, and Creative Thinking

EMPLOYMENT HISTORY

PUREPAC PHARMACEUTICAL COMPANY ~ ELIZABETH, NJ: 2001–2005

Qualification Engineer, Equipment Qualification 2002–2005
Prepared and generated the commissioning and qualification protocols for equipme
nt qualification. Collaboratively worked with upper management and different fun
ctional areas to resolve any deviations that occurred during the qualification.
Partook in various group activities to perform qualification protocol assessment
s. Regularly interfaced with contractors to review the protocols they generated
in adherence to the current good manufacturing practice (cGMP), manufacturer spe
cifications, and company requirements.
Notable Contributions:
- Established and implemented qualification protocols within different dep
artments, such as Technical Services, Research and Development (R&D), Manufactur
ing, Planning, Supply Chain, Engineering, and Maintenance
- Conceptualized engineering studies for new equipment, such as metal dete
ctors and capsule polishers
- Played key role in executing engineering studies and writing final repor
ts for engineering studies
Associate Research Scientist II, Technical Services 2001–2002
Primarily held responsibility for reviewing validation protocols and reports, wr
iting technical reports for exhibit batches, and evaluating the process. Assesse
d and approved Master Formula for scale-up. Troubleshot manufacturing problems a
nd offered technical support during exhibit and validation batches. Examined the
root cause of product and process non-conformances. Convened with Quality Assur
ance Department for process, cleaning and equipment validation tests sampling. W
orked closely with Engineering and Maintenance departments as necessary to modif
y the environmental conditions according to batch records.
Notable Contributions:
- Meticulously managed all aspects of exhibit batch manufacturing of new p
roducts on time and adherent to cGMP, for stability and bio-study
- Provided expert oversight to technology transferred products and process
validation of new products
- Served as a significant contributor in SUPAC changes for current product
s during pre-validation or Food and Drug Administration (FDA) submission phase
- Conceptualized and implemented procedures and protocols for IQ/OQ/PQ for
manufacturing and testing equipment of solid-dose drugs
- Displayed unsurpassed expertise in achieving significant cost savings an
d managing system set-up projects

BECTON DICKINSON & COMPANY ~ FRANKLIN LAKES, NJ: 1999–2000

Engineer, Research & Development 1999–2000
Engineering Intern, Research & Development 1999
Supervised all phases of manufacturing and testing, and provided computer softwa
re assistance. Facilitated training to laboratory assistants to enhance their co
mpetencies in various applications. Performed comprehensive research and testing
of new and already-existing products. Delivered informative presentations compa
ny-wide regarding the latest projects. Interfaced with different departments, su
ch as QA, RA, Statistics, and Production.
Notable Contributions:
- Drove all efforts in creating and implementing manufacturing processes f
rom inception to completion
- Demonstrated expertise in writing protocols, technical reports, test pro
cedures, operating instruction process, and product specifications
- Presided over the modification and installation of new equipment for pro
totype production
- Rendered high level of assistance in all aspects of IQ, OQ, and PQ for n
ew products
- Received commendation for designing the test protocols for product evalu
ation

EDUCATION
BACHELOR OF SCIENCE IN CHEMICAL ENGINEERING ~ New Jersey Institute of Technology
, Newark, NJ: May 2000

TECHNICAL PROFICIENCY
SOFTWARE: Microsoft Office Suite (Excel, Word, and PowerPoint), WordPerfect, and
 Engineering Graphics Pro 18
PROGRAMMING LANGUAGES: C+ and QBasics