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.

*

Bachelor of Pharmacy, B. Pharm (Hons) 1974-1978 Major in Pharmaceutical Chemistry. from Birla Institute of Technology & Science, Pilani (Rajasthan), INDIA.