Pallavi Kulkarni
Executive QA-RA
Andheri, Mumbai,MH
Summary
Dynamic Quality and Regulatory Affairs Professional with over 8 years of experience in the pharmaceutical industry, demonstrating a strong understanding of drug compliance and regulatory standards. Committed to ensuring the quality, safety, and efficacy of pharmaceuticals to protect public health. Proficient in Microsoft Office Suite, Adobe Reader, and regulatory submissions, with a proven ability to compile dossiers and effectively address regulatory queries. Expertise includes exceptional communication skills, quality management systems (QMS), specifications, standard operating procedures (SOPs), market complaints, corrective and preventive actions (CAPA), change controls, deviations, validation processes, and out-of-specification (OOS) investigations.
Overview
10
10
years of professional experience
2
2
Certifications
Work History
Executive QA-RA
Indo German Alkaloids
12.2024 - 07.2025
- Developed and implemented quality assurance protocols, enhancing compliance with regulatory standards and improving overall product safety.
- Led cross-functional teams in root cause analysis, effectively addressing quality issues and fostering a culture of continuous improvement.
- Spearheaded the validation of manufacturing processes, ensuring adherence to industry regulations and enhancing operational efficiency.
- Conducted comprehensive audits of quality systems, identifying gaps and implementing corrective actions to maintain regulatory compliance.
- Partnered with regulatory agencies to streamline approval processes, resulting in faster time-to-market for new products.
- Mentored junior QA staff, providing guidance on best practices and promoting a collaborative team environment focused on quality excellence.
- Prepared and reviewed dossiers for ROW markets.
Executive QA/RA
Vardhman Exports
08.2022 - 12.2024
- Review product dossier & communicating the gaps/issues found related to new & existing products supplied to company, review and prepare technical documents like FPS/MOA, IPS/MOA, RMS & PMS required for variation/ Dossier submission
- Review of ongoing stability data of all products manufactured & communicating for deficiencies found in provided data for rectification
- Timely review, handle and maintain technical documents like Manufacturing Licenses / Product Permissions, GMP Certificates, test license and COPP
- To prepare SOPs & other quality documents followed by issuance of these formats / SOPs to concerned departments & retrieval of obsolete documents from respective departments by maintaining log of the same
- To follow up & tracking of timely closure of CAPA resulted from observations/ deficiencies found during facility audit/visits/OOS/deviations/change controls/market complaints/NSQ/other FDA issues
- Conversant with computer knowledge in preparation of presentation documentation related to QMS
- Prepare response to regulatory deficiencies letters according to regulatory requirements
- Responsible for keeping system up to date and accurate, Maintain lists/documents/records
- Review of plant and R&D documentation such as BMR, BPR, CMC documents, Specifications, APQRs, Quality manuals, SMF, validation documents.
Officer QA
ORIKAM HEALTHCARE INDIA PVT.LTD.
08.2021 - 01.2022
- Initiation, review, monitoring, tracking and closure of change controls
- Prepare and review the standard operating procedures (SOP’s) and confirm its periodic updation
- Review of filled batch record
- Internal Audits, Trainings and maintain SOPs/Documents/Formats/License
- Document circulation and control
Officer QA
Ajanta Pharma Limited
04.2017 - 08.2020
- Batch record preparation i.e. BMRs of Tablet, Capsules, Powder formulation and BPRs of blister pack, strip pack, sachets pack and bulk pack
- Annual updating of batch records to regulatory affairs
- Review of filled batch record, Master Formulae records, Master packaging records
- Initiation, review, monitoring, tracking and closure of change control in QMS system
- Document’s control (Issuance, retrieval, archival & destructions)
Assistant QA officer
Savera Pharmaceuticals Pvt. Ltd.
12.2015 - 03.2017
- Preparation, issuance, controlling & revision of SOPs
- Preparation, controlling, issuance & revision of BMR & BPR
- Initiation, review, monitoring, tracking and closure of change control
- Review of Batch Documents (i.e. BMR, BPR, Analytical reports)
- Assist in Handling Market Complaint, Internal Quality Audit, CAPA management
Trainee QA
Skybiotech Life Science Pvt. Ltd.
05.2015 - 11.2015
- Monitoring dispensing of Raw materials
- Monitoring in process control in manufacturing & packing
- Monitoring line clearance activity for all manufacturing and packing activities
- Monitoring environmental conditions and area clearance
- Monitoring IPQA Activities like hardness, friability, leak test, sampling of bulk, intermediate and FP
Education
Master of Pharmacy - Pharmaceutics
Dr. Babasaheb Ambedkar Marathwada University
Aurangabad, Maharashtra01.2015
Bachelor of Pharmacy - Pharmacy
Swami Ramanand Tirth Marathwada University
Nanded, Maharashtra01.2013
Skills
Regulatory compliance
CAPA management
Technical document review
SOP development
Product dossier preparation
Internal audits
Quality management system (QMS)
Documentation control
Regulatory agency liaison
Batch record review
Stability data review
Hands on microsoft office
Manufacturing process validation
Certification
- Executive Diploma in Pharmaceutical Regulatory Affairs
- IGMPI - Institute of Good Manufacturing Practices India
COURSEWORK
- National Level Paper Presentation On “Antihyperglycemic effect of gliclazide implants in alloxan induced diabetic rabbits”
- Attended 66th Indian Pharmacy Council, 2015, at Hitex City Hyderabad on subject “Joint Venture Partnership”
- Completed One Month Industrial Training at Wockhardt Limited, Biotech Park, M.I.D.C., Waluj, Aurangabad-431136
Timeline
Executive QA-RA
Indo German Alkaloids
12.2024 - 07.2025
Executive QA/RA
Vardhman Exports
08.2022 - 12.2024
Officer QA
ORIKAM HEALTHCARE INDIA PVT.LTD.
08.2021 - 01.2022
Officer QA
Ajanta Pharma Limited
04.2017 - 08.2020
Assistant QA officer
Savera Pharmaceuticals Pvt. Ltd.
12.2015 - 03.2017
Trainee QA
Skybiotech Life Science Pvt. Ltd.
05.2015 - 11.2015
Master of Pharmacy - Pharmaceutics
Dr. Babasaheb Ambedkar Marathwada University
Bachelor of Pharmacy - Pharmacy
Swami Ramanand Tirth Marathwada University