Ashesh Gupta

I have worked in the pharmaceutical industry for over 30 years. I am retired now. But I want to pursue a career in sales. My passion is in sales. I started my career after college in Pharmaceutical Sales in India.

Then migrated to the US in 1982, and worked in the hospital for several years as a Pharmacy Technician. Then from 1988 to 2023 worked in the pharmaceutical industry as a Research Scientist ( 18 years) and Quality Specialist (17 years). 

I am a very detail-oriented individual, very organized. In other words I am a perfectionist.

Ashesh Gupta
Richmond, VA 

mitash1027@gmail
 

SUMMARY
 Senior Research Professional with excellent people and point person skill
 Proficient in balancing multiple projects with rigid timelines.
 Strong work ethic with an outstanding record of achieving in time completion of project
milestones.
 Extensive experience in Quality Assurance data review.
 Experienced in multiple inventory systems.
 Skilled at learning new concepts, working well under pressure, adaptable to ongoing changes, and
communicating ideas clearly and effectively. Excellent time management and stress management
skills.
 Able to independently drive and effectively manage numerous tasks in a timely manner.
 Proficient in Microsoft PowerPoint, Word, Excel
 Six Sigma Yellow Belt Certified.
 Detailed knowledge of GMP, FDA regulations and guidelines.
 Analytical and Disciplined problem-solver.
 Motivates co-workers through creating the vision of how ideas and projects will benefit
customers.
PROFESSIONAL EXPERIENCE
Indivior Inc.
Product Quality Lead 2022 – 2023
 Virtual Batch Record Review (BRR) and Packaging Record Review (PRR) of Indivior film products
manufactured by CMO (Contract Manufacturing Operation) and packaged by CPO (Contract Packaging
Operation).
 Review BOM’s (Bill of Materials) with respect to Artwork
 Reviewing of Temperature Excursion data for products shipped from CMO to CPO.
 Review of Deviations, NCR’s (Non-conformances), OOS’s (Out of Specifications), Change
Controls.
 Review and disposition of BR
 Review of COC (Certificate of Conformance) & COR (Certificate of Release)
Ashesh Gupta
Mayne Pharma (Greenville, NC) 2017 – 2022
Quality Assurance Specialist
 Detailed Auditing of internal client data packets, including Laboratory Notebooks, COA’s (Certificate
of Analysis), Analytical Reports, ASTD’s (Analytical Standards), Methods.
 Analyzing specification documents for all Pre-Commercial CTM’s (Clinical Trial Materials), for all oral
solid dosage forms.
 Auditing of Stability Data packets throughout the life cycle of the study, for over 100+ clients,
including, CTM’s, Commercial and Pre-Commercial products.
 Verification of all Purchase Specifications, namely, API’s (Active Pharmaceutical Ingredients), Raw
Materials and excipients.
 Auditing of Laboratories, Manufacturing areas, Packaging lines, Shipping, Warehouse, including the
HVAC system and the filters. Communicate with a detailed report to the QA (Quality Assurance)
Management team.
 Room clearance sign-off in the batch records, verification of CV’s (Cleaning Verification), CTM labels,
packaging lines and labels.
 Responsible for verifying pre cleaning of equipment log and room log prior to room clearance signoff.
Pfizer Consumer Healthcare, Richmond, VA 2015 - 2017
Flavor Technology and Product Technology & Support (PT&S) Research Scientist
 Performed cGMP manufacturing …Weighing, Blending, Compression and Coating processes.
 Responsible for developing samples for flavor tasting.
 Responsible for documenting the pertinent information accurately into the flavor technology library.
 Responsible for tracking all inventory controls (flavor and taste masking reagents) into the database.
 Responsible for archiving of all old Alacer Corporation, CA, files into QA Archival Templates
 Completed all tasks in a timely manner
Pfizer Consumer Healthcare, Richmond, VA 1991 – 2014
Quality Assurance
Senior Quality Associate (4/2009 – 01/2014)
 Responsible for 3rd party contractors to ensure their needs were met by releasing products on time
to meet customers’ needs.
 Developed the ‘List 1 Chemical Process’ of receiving the product and its destruction.
 Authored the SOP accordingly.
 Performed electronic Batch Record Review and Disposition daily in a timely manner to meet
customer needs using SAP system and SQL LIMS LabWare system.
 Approved BOM’s (Bill of Materials) on a routine basis, in SAP, within 24 - 48 hours of submission.
Ashesh Gupta
 Coordinated with vendors, external, internal (packaging engineers) to verify codes used in BOM,
before final approval in SAP.
 Managed List 1 Chemical Samples (e.g., Pseudoephedrine, Ephedrine) manufactured by 3rd party
contractors.
 Approved Master Data in a timely manner, using Enterprise Resource Planning (SAP), reduced the
turnaround time from 7 days to 2 days. Lead the processes and was instrumental in accomplishing
the reduced timeline.
 Created metrics for Global QA with regards to QTS data, namely, Annual Product Review,
Complaints, Commitments, and Occurrences on a weekly basis. These metrics enabled the Senior
Management Team to review all data and manage backlogs, using PowerPoint.
 Streamlined the process of preparing CPSIA-COC (Consumer Product Safety Information Act-
Certificate of Compliance) certificates for FDA. Lead the process for creating certificates within 24
hours of product release (e.g., Ibuprofen, Acetaminophen, and Diphenhydramine HCl).
Raw Materials Product Development
Analytical Scientist III (08/2003 – 4/2009)
Per FDA regulation tested all in-house raw materials used in Pfizer consumer products.
 Authored several Raw Material Monographs, Method Validation Protocols and Reports.
 Performed Wet Chemistry analysis based on USP, EU, and JP methods in a timely manner for raw
materials logged daily.
 Proficient in FTIR Spectroscopy and HPLC (High Performance Liquid Chromatography).
 Successfully cross-trained in performing Folic Acid Validation for Centrum Cardio by HPLC method.
Accomplished successful dissolutions of various Stability samples to avoid backlogs.
Stability Services and Physical Testing Laboratory
Analytical Scientist II (07-1991 – 08/2003)
Supervised 3 scientists to ensure the stability samples were tested within 30 days of receipt in the lab.
 Successfully developed 14 Physical Test Methods for Primatene Mist Spray
 Developed the first Particle Size Analysis method for Ibuprofen by Laser Diffraction Technique.
 Authored several Basic Operating Procedures (BOP), Standard Operating Procedures (SOP) and
Physical Test Methods (PT).
 Authored several Stability Protocols for various Pfizer products.
 Maintained and monitored Stability Chambers for various stability studies.
PRIOR EXPERIENCE
Medical College of Virginia; Richmond VA
Assistant Pharmacist
Executed physician's order and Prepared IV, Chemotherapy, hyperalimentation fluids, and Delivered IV fluids
to the respective nursing units.
Ashesh Gupta
EDUCATION
BS, Pharmacy (Hons.) Pharmaceutical Sciences, Birla Institute of Technology & Science (BITS), Pilani
(Rajasthan), India.
TECHNICAL SKILLS
Proficient in Microsoft Office—Word, Excel and PowerPoint. Proficient in Microsoft Outlook Express. Also,
very proficient with QAD, Empower 2 & 3, SLIM, SAP-CAPA, SAP Master Data Approval, QTS, NovaManage,
LIMS LabWare, Trackwise.
MEMBERSHIP & AFFILIATION
Member of ASQ (American Society of Quality).
Volunteered at Habitat for Humanity in Richmond, VA.
Volunteered at Big Brother and Big Sister of Central Virginia in Richmond, VA.
Volunteered at Washington Football Team Training Camp in Richmond, VA.
Volunteered at Richmond Kickers Soccer Games in Richmond, VA.
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Bachelor of Pharmacy, B. Pharm (Hons) 1974-1978 Major in Pharmaceutical Chemistry. from Birla Institute of Technology & Science, Pilani (Rajasthan), INDIA.