Quality Assurance Product Management

Priyanka Pravin Choudhari

**************@*****.*** 858-***-**** linkedin.com/in/priyanka-choudhari612 PROFESSIONAL SUMMARY

Goal-directed, result-oriented professional with a strong technical background and experience of Quality Assurance along with knowledge of FDA/EMEA standards. Good leadership skills in management of interdepartmental teams ensuring compliance with regulations and internal quality standards. Ability to work analytically and efficiently in timely fashion.

EMPLOYMENT HISTORY

Quality Assurance Specialist 2

Gilead Sciences Inc, Foster City March 2025 - Present External Quality Operations:

o Review and approve master batch records, executed production batch records, specifications and other associated documents for Commercial API in compliance with FDA and international health agency requirements. o Coordinated any deviations, investigations, corrective and preventive action (CAPA) recommendations and used root cause analysis tools. o Interfaced directly with contract manufacturers and alliance partners to manage quality related issues. o Maintained routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices

(GMPs) and Good Laboratory Practices (GLPs).

o Worked in APQR for commercial API projects; mainly focused on usage of Discoverent system. o Proficient in using quality applications – QMS (Quality Management System), Vault, SAP (Systems, Applications, and Products), IQS, LIMS

(Laboratory Information Management System), GPLM (Gilead Product Lifecycle Management), GXP training environment. Quality Assurance Specialist 1

Gilead Sciences Inc, Foster City August 2022 - February 2025 External Quality Operations:

o Review and approval of batch records, labels, analytical documents, and compliance reports for clinical as well as commercial oral solid dosage forms, parenteral, biologics and API (Active Pharmaceutical Ingredient). o Review and approval of packaging documents through GPLM (Gilead Product Lifecycle Management) application. o Ensured regulatory requirements through GRASP application. Decision making regarding product disposition, including release, rejection, or reprocessing and performed disposition in Oracle EBS application. o Assess the impact of changes on product quality and regulatory compliance, ensuring that changes are implemented in a controlled and documented manner.

o Assists as coordinator with deviation, investigations, and corrective and preventive action (CAPA) recommendations related to manufactured products.

o Interact with key stakeholders such as Formulation and Process Development, Manufacturing, Packaging, and Regulatory Affairs to ensure that Clinical/Commercial Drug Products are manufactured in accordance with established procedures and appropriate regulations. o Working directly with Contract Manufacturing Organizations and alliance partners to manage quality issues. o Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).

o Contributed in multiple Clinical OSD (Oral Solid Dosage) projects. Worked on new product introduction in Phase 1. Formulation Intern

BioDuro-Sundia, San Diego July 2022 – August 2022

o Assisted in lab scale work, collecting data from executed batch records and protocols. o Handled equipment such as particle size analyzer, vertex mixer, sieve shaker, pH meter, centrifuge, sonicator, tap density apparatus, friability test apparatus, disintegration tester, hardness tester and chromatography instruments. Teaching Assistant

University of California San Diego January 2022 - March 2022 o Course BIMM 118 Pharmacology

Quality Assurance Senior Executive July 2019 - August 2021 Cipla Ltd, Patalganga, India

Section QMS (Quality Management System):

o Managed Change Controls, Risk Management and SOP (Standard Operating Procedure) through CIPDOX software. o Drafted and implemented changes to SOPs (Standard Operating Procedure). Developed and delivered training programs for employees on quality policies, procedures, and regulations.

o Directed training using LMS software (Learning management system). o Tracked nonconformance through Deviation and CAPA (Corrective Action and Preventive Action). o Managed OOS (Out of specification), OOT (Out of trend), market complaints and Data Integrity cases. o Participated in root cause analysis and investigations. o Used tools such as FMECA (Failure mode effects and criticality analysis) and 5 Why analysis. o Maintain accurate and up-to-date documentation of all quality-related activities including key job responsibilities and organization chart. o Successfully managed USFDA and internal audit.

o Conducted audit rounds and ensured that all guidelines (ISO, ICH, cGMP, GLP, GDP) are followed within the industry. o Presented in weekly and monthly Quality Management Review meetings. Followed ALCOA plus principle. Section IPQA (In Process Quality Assurance):

o Review of documents- BMR (Batch Manufacturing Record), BPR (Batch Packaging Record) and APQR (Annual Product Quality Review) along with the Audit Trail.

o Monitored the batches from dispensing stage to dispatch stage. o Performed line clearance and area clearance for the batch events. Performed in process checks at manufacturing and packing stage. o Conducted rejection analysis of raw materials. Checked daily reports of alarms and logbooks. o Checked on cleaning, process, and equipment validation. o Checked on Installation Qualification, Operational Qualification and Performance Qualification for equipment. o Managed operational software’s - SAP (Systems, Applications & Products in Data Processing), SCADA (Supervisory Control and Data Acquisition), TrackWise and CENTRACK AG SERVER.

Pharmacy Intern May 2018 - June 2018

Sangeeta Pharma, Jawahar Co-operative Industrial Estate, Kamothe, India o Learned the workflow of Stores, Production, Quality Control and Quality Assurance department for the oral liquid formulations. Community Pharmacist Intern June 2017 - June 2017

Santosh Enterprises, Kalamboli, India

o Ensured the safe and correct supply of medicines with appropriate labels. o Maintained the proper arrangement of medications. o Instructed patients regarding the intake of the formulations. o Updated the record of the sale and placed order for medicines and nutritional supplements as per the requirement. Community Pharmacist Intern June 2016 - June 2016

Vega Chemist, Kamothe, India

o Ensured the safe and correct supply of medicines with appropriate labels. o Maintained the proper arrangement of medications. o Instructed patients regarding the intake of the formulations. o Updated the record of the sale and placed order for medicines and nutritional supplements as per the requirement. EDUCATION

University of California San Diego September 2021 - June 2022 Master of Science in Drug Development and Product Management (MS) La Jolla, USA University of Mumbai 2015 - 2019

Bachelor of Pharmacy (B Pharm) Mumbai, India

TECHNICAL SUMMARY

License: Registered Pharmacist

Certifications: Maharashtra State Certificate in Information Technology (MSCIT), Quality by Design course by Pharma Literati, Career Management by Harvard Business Publishing, Marketing Essentials by Harvard Business Publishing, Finance Essentials by Harvard Business Publishing, Lean Six Sigma Green Belt, Technical Writing: Quick Start Guides by Leslie O'Flahavan. Technologies: Microsoft Office, Google forms, Zoom, Microsoft Teams, SQL, R software. SKILLS

Medical device safety and compliance Regulatory Affairs Clinical research Lab testing Microbiology Chemistry Biochemistry Sales

HPLC Lab work

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