RASHMI TANEJA, PH.D.
2 Revere Court * Princeton Junction, NJ 08550
 * (C)  [Send email to request phone number] 40-4218 * (H)  [Send email to request phone number] 99-5996
Management of Quality Assurance, Quality Control and Manufacturing
Highly successful executive with a demonstrated track record of organizational
leadership and management in the pharmaceutical and nutritional products. Known
for ability to reorganize a company structure leading to increased profits and
staff productivity. Extensive experience in quality assurance, process
development/optimization, process validation, and quality control. Able to
deliver cost-effective and tactical quality solutions that comply with FDA
regulations.
Recognized for exceptional communication and problem solving skills. Talent for
motivating employees, developing managers into effective leaders, and preparing
them for growth and expansion of the organization. A dynamic change agent able to
lead through and manage change using innovative, out-of-the box approaches.
Core Knowledge, Skills, and Abilities:
 * Strategic & Tactical Planning
 * Executive Management
 * Creative Problem Solving
 * Budgeting & Forecasting
 * Leadership & Team Building
 * Product Development
 * Technology Transfer/Scale-up
 * FDA, EPA & ISO Regulations
 * Technical Writing - Methods & protocols
 * Equipment/Computer Validation (IQ/OQ/PQ)
 * Quality Assurance and Quality Control
 * Interpretation of cGMP/GLP, cGxP Training

PROFESSIONAL EXPERIENCE

CMIC-VPS Corporation (formerly VPS Corporation, A Subsidiary of Freund /Vector &
CMIC Corporation), Cranbury, NJ
DIRECTOR & EXECUTIVE VICE PRESIDENT, 2006 - 08/2009, (Consultant: 08/2009 to
Present)
VICE PRESIDENT OF QUALITY CONTROL & QUALITY ASSURANCE 2001 - 2009
Concurrently held roles of increasing responsibility including Management of
Quality Assurance and Quality Control culminating with Operations responsibility
as an executive. Quickly accelerated through the ranks, becoming the Company's
first VP of Quality. Charged with management of total quality, continuous
improvement and regulatory requirements including: the development and validation
of manufacturing processes and finished formulations, equipment validation,
analytical method development/validation, analysis of raw materials, in-process
and finished products. Identified cGMP deficiencies in the manufacturing,
laboratory, engineering and quality departments and provided cGxP training.
Oversaw the development of business systems including technical transfer,
clinical, & commercial production activities.

Site Head and member of the Board of Directors with complete P&L responsibility
and oversight of all operational functions of the company, including staff
supervision & career development, formulating policies, coordinating
relationships and resources across key business functions: Manufacturing, Quality
Assurance, Sales, Analytical Development and Validation, Quality Control,
Business Development, Financial Planning, and Human Resources. Manage the
company's solid dosage products from formulations or technical transfer to
clinical and commercial (GMP) production for both generic and brand drug name
products. Serve as the senior advisor to the executive management team in Japan.

Key Achievements: Quality Operations
 * Hosted GMP audits from regulatory agencies and customers and obtained
pre-approval inspections for various products based on US, EU, and JP
regulations. Passed all customer audits which resulted in procuring new business
contracts amounting to approximately $4.5 million each year.
 * Addressed and corrected Form 483 issues when hired resulting in a track
record of either none or minimal citations in the next four FDA inspections.
 * Directed the design for renovating the existing manufacturing facility and
newly equipped a state-of-the-art laboratory. Oversaw all validations and quality
issues to ensure cGMP compliance.
 * Conducted internal and external audits to evaluate full-cycle GMP compliance
and led all FDA and global regulatory inspections. Initiated corrective &
preventive actions (CAPA) to capture quality metrics & enhance performance.
 * Created Drug Master Files, INDs, CMC section for NDAs and ANDAs, computer
validations, process validation master plans, equipment validations (IQ/OQ/PQ),
and cleaning validation reports. Revised numerous manufacturing, quality and
laboratory SOPs.
 * Investigated deviations for root cause analysis and proposed solutions and
guidance to manufacturing. Conducted investigations for out of specification
results in analytical or manufacturing areas providing trended analytical data.
 * Initiated and built a fully compliant stability program from scratch. This
new venture for our company has generated revenues of $0.5 million each year.
 * Developed additional business by creating a companywide climate of concern
for quality manufacturing that earned the respect of clients and regulatory
officials.

Key Achievements: Business Operations
 * Converted the manufacturing operation from an R&D/clinical site to a
commercial manufacturing plant. Oversaw construction of new facility and
installation of commercial scale equipment to produce commercial quantities of a
generic drug which resulted in a ten fold increase in revenue and greater than a
40% profit margin.
 * Restructured operating budgets for equipment, facilities, and personnel;
negotiated favorable contracts with suppliers, and devised new methods to improve
operating systems efficiency and lean cost/price structure.
 * Assembled a professional staff from different disciplines, leading the group
to plan, formulate and implement comprehensive quality and performance
improvements, and environmental health and safety policies throughout the
organization.
 * Created short and long-term business plans and pursued and developed new
business relationships and potential service offerings with suppliers and
potential customers.
PURDUE BIOPHARM (acquired Cytogen manufacturing), Princeton, NJ, 1999 - 2000
CONSULTANT, QUALITY CONTROL MANAGER
Consulted with the QC department for pharmaceutical biologic products in support
of manufacturing and purification. Planned the development and validation of
methods, wrote SOPs, executed and oversaw equipment validation (IQ/OQ/PQ), and 21
CFR Part 11 compliance of all laboratory equipment.
 * Identified and corrected problems with existing methods saving the company $5
million by extending the shelf life of a product.
 * Resolved pre-existing FDA issues and continued to improve procedures and
practices to bring the laboratory into compliance with cGMP/GLP standards.
AMERICAN CYANAMID (now American Home Products), Princeton, NJ, 1991 - 1999
SENIOR RESEARCH CHEMIST (1997 - 1999), RESEARCH CHEMIST (1991 - 1997)
Supervised technical activities of staff members, contract laboratories, and of
manufacturing facilities. Developed and validated analytical methods (HPLC and
GC) for company products for formulation and process development, clinical
studies, NADA stability studies, manufacturing, and release. Resolved compliance
issues related to FDA GLP/GMP regulations and OSHA requirements. Wrote SOPs and
job hazard analyses (JHAs).
 * Successfully completed a comprehensive FDA study audit, resulting in removal
of an existing Application Integrity Policy Sanction allowing the company to once
again register products.
 * Modified an existing bioanalytical method, which resulted in a cost savings
of $100,000 per year.
 * Provided the FDA with a site qualification plan, which was used by the FDA as
a model for other companies doing similar work.
 * Developed and validated a quality clean-out method under very challenging
deadlines with average recoveries that were 15 percent greater than existing
methods.

ROCKLAND COUNTY SEWER DISTRICT 1, New York, NY, 1988 - 1991
LABORATORY DIRECTOR/POLLUTION CONTROL SUPERVISOR
Managed and gave technical direction for chemical and biological analyses of a
state-of-the-art, New York State-certified laboratory serving a sewage treatment
facility. Ensured GLP compliance using EPA regulations.

EDUCATION

Ph.D. - Organic Chemistry, New York University (with courses in biochemistry,
microbiology and statistics)
M.S. (Honors) - Physical Chemistry, Panjab University (India)
B.S. (Honors) - Physical Chemistry, Panjab University (India)

PROCESS/ANALYTICAL EXPERTISE

Analytical: Chromatography (HPLC, GC, TLC); Dissolution, Spectroscopy (UV-VIS,
FT-IR, NMR, MS); LC-MS, GC-MS, AA, ICP, TOC, Microtox, Karl Fisher Titration.
Assays used for analyzing raw materials, in-process and finished products,
proteins (using HPLC-ion exchange and size exclusion chromatography, SDS-PAGE,
ELISA, LAL, etc.). Excipient testing, compendial procedures, special methodology
for protein analysis included HPLC-ion exchange and size exclusion
chromatography, SDS-PAGE, ELISA, LAL, video densitometry, microplate reader, and
gamma counter.
Process: Equipment for solid dosage forms included fluid bed dryer, granulator,
coater, co-mill tablet press, capsule filler, and Spherex for seamless
mini-capsules.

PROFESSIONAL DEVELOPMENT COURSES

& CERTIFICATIONS

 * Clinical Research and Study Design, 3/2010
 * ASQ-Ceritified Quality Manager, 3/2010
 * Drug Master Files, December 2009
 * Pharmaceutical Industry Seminar by Central Association of Food and Drug
Officials, 2009
 * International GMPs: Complying with the requirements in the U.S., EU, and
Japan, 2006
 * Master Cleaning Validation Program, 2005
 * Auditing and Qualifying Suppliers and Vendors, Pti International, 10/2004
 * How to prepare and write IND's, NDA's and Post Approval Documents, 11/2003

 * Living Leadership, 10/2003
 * Pharmaceutical Stability Testing, 12/2002
 * Legal Implications of FDA inspections and non compliance 1/2001
 * Statistical Analysis in the Laboratory, American Chemical Society, 1997
 * The Role of Quality Control/Quality Assurance in Pharmaceutical
Manufacturing,