Kirti Choksi has over 20 years of experience in quality assurance, regulatory, and compliance roles in the pharmaceutical and biotechnology industries. She has worked for companies such as Pfizer, Johnson & Johnson, and EUSA Pharma, where she managed quality reviews, audits, and ensured compliance with FDA regulations. Choksi's experience includes developing strategies, policies and procedures, as well as authoring documents like annual drug product review reports. She has expertise in areas such as GMP, GCP, clinical trials, and regulatory submissions to bodies like the FDA and EMA.

1. Kirti Choksi Confidential Page 1
KIRTI CHOKSI
88 Columbus Drive, kchoksi57@hotmail.com
Franklin Park, NJ 08823 Tel # 732-297-8151
QUALITY ASSURANCE / REGULATORY / COMPLIANCE
 Proactively Managed Third Party Manufacturers, Suppliers and Vendors in USA, Canada and U.K.
 Extensive Pharmaceutical and Biotechnology industry experience focused on GXP, FDA and EU.
 Demonstrated expertise in strategic planning, organizational development and team building.
 Excellent leadership, communication, trouble-shooting and motivation skills that effectively interact
with staff, customers and executive management.
PROFESSIONAL EXPERIENCE (Consulting Assignments):
ETHICON INC, Somerville, NJ
Technical Writer/Procedure Author 04/2014 to 10/2015
 Developed and Reviewed stability strategies, protocols and reports in support of the product
development process.
 Developed Policies, Procedures, Work Instructions, Forms, and Templates.
 Subject Matter Expert of Medical Devices, Biotech, Pharma & Consumer Products
Supporting Documents Program.
PFIZER, Bridgewater, NJ
Compliance Analytics, Worldwide Safety and Regulatory 03/2013 to 12/2013
 Performed quality reviews of submission data and business processes/procedures to support
continuous process improvement and organizational evolution, driving timely measurable and
actionable feedback for proactive changes (ARGUS).
 Collaborated effectively with the Business Units and Partner Lines.
J & J CONSUMER PRODUCTS, Skillman, NJ
Technical Writer 02/2012 to 01/2013
 Wrote Annual Drug Product Review Reports.
 Familiar with Documentum, LIMS, Sharepoint, GARNET, GSS, CONNECT, and ETQ
System Soft Wares.
ORAPHARMA, Inc., Warminster, PA
Quality Assurance 01/2011 to 01/2012
 Performed the audit of Suppliers, Vendors and Distribution Centers in compliance to cGMP, FDA
and Canadian Regulations.
 Created Annual Product Reports for management review.
 Experienced Auditor, Ensuring Compliance with Regulations.
EUSA PHARMA (USA), Inc., Langhorne, PA
Quality Assurance and Regulatory Affairs 09/2008 to 12/2010
 Reviewed and Approved Return Authorizations, Deviations, Discrepancy, OOS & OOT
Investigations, CAPAs, Complaints, Labels, Batch Records, Contracts, Quality Agreements, Audits,
Inspections, Change Controls, CMC Drug Developments, Clinical Trials (I to IV), IND, NDA, BLA,
PMA Submission Documents and Validation Records for 4 different CMO’s manufacturing
Oncology Products.
 Experienced in the review of promotional materials (including red-line documents) of off label and
on label attributes.
 Resolved Technical Problems, Ensuring Compliance with FDA and ICH guidelines.

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SCHERING-PLOUGH CORPORATION, Kenilworth, NJ
GCP Compliance Audit & CAPA 03/2007 to 07/2008
 Created and Implemented CAPA process for the review of executive management.
 Ensured Resolution of Audit and Inspection findings through Completion of Corrective and
Preventative Actions (CAPAs).
 Performed GCP Audits, TMFs, Study Sites, and Pre-Approval Inspection readiness audit.
 Reviewed FDA and MHRA inspection reports and responses from internal project managers.
 Managed Tracked and Trended FDA and MHRA observations and reported them for the review
of Executive Management on a weekly basis.
 Maintained a CAPA Project for Executive Management with 0 tolerances.
ORTHO CLINICAL DIAGNOSTICS, Raritan, NJ
QA Compliance Auditor 05/2006 to 12/2006
 Performed internal Labs, Sterile Manufacturing Facilities (cGMP) and external (Vendors and
Suppliers) audits to ensure that key activities were in compliance with the requirements of ISO
13485:2003, EU, and FDA regulations Title 21 CFR Part 11, Part 210, Part 211, Part 600 and Part
820 - Quality System Regulations.
 Evaluated audit deficiency responses and corrective/preventive action plans (CAPAs) to address
audit deficiencies (TrackWise).
 Experienced in reviewing IND, NDA, BLA and PMA documents during FDA inspection.
 Managed Internal and External Compliance Audits.
PROFESSIONAL EXPERIENCE (Permanent Positions):
LABORATORY CORPORATION OF AMERICA, Raritan, NJ
Clinical Trials GCP Auditor 09/2004 to 05/2006
 Conducted audits for the Regulatory/QA function within Internal (Laboratories) and External
Clinical Trials (Phase I to IV) in order to assure compliance with GCP in accordance with established
FDA regulations, ICH Guidelines, European Directives on GCP 2001/20/EC and Lab Corp
Policies.
 Managed FDA Inspections and Sponsor Audits.
ORTHO CLINICAL DIAGNOSTICS, Raritan, NJ
R & D and QA Scientist 10/1994 to 09/2004
 Managed Stability for HCV, HIV, HTLV, HBsAg, and HCV Core Antigen products.
 Managed QA group, Investigations, Deviations and CAPAs.
 Released products & raw materials as per cGMP and FDA Regulations
 Recognized for reliability and "getting the job done" through persistence and a strong work
ethics.
EDUCATION & LICENSES:
 Bachelor of Science, Major-Microbiology, Minor –Biology
Sardar Patel University, Vallabh Vidyanagar, Gujarat, INDIA.
 Medical Laboratory Technician
K. M. Medical School, Ahmadabad, Gujarat, INDIA
 National Certificate, Medical Laboratory Science.
Willesden College of Technology, London. U.K.
 Higher National Certificate, Medical Microbiology.
Salisbury College of Technology, Salisbury, Wiltshire, U.K.
 Laboratory Technician.
New York Department of Health, New York, U.S.A.
COMPUTER SKILLS:
MS Office (MS Access, MS Excel, MS Word and MS PowerPoint.