Poornima Shetty
Boisar
Summary
Dynamic Quality Assurance professional with extensive experience at Naprod Life Sciences Pvt. Ltd. Proven track record in managing Quality Management system and compliance audits, enhancing operational efficiency. Skilled in document control and team leadership, adept at implementing quality protocols. Committed to continuous improvement and regulatory adherence, ensuring product safety and quality.
Overview
16
16
years of professional experience
Work History
Assistant Manager Quality Assurance
Naprod Life Sciences Pvt. Ltd
Boisar
10.2023 - Current
- Experienced in end-to-end Quality Management System (QMS) operations, including Change Control Management, CAPA (Corrective and Preventive Action) Management, and investigation handling for OOS (Out of Specification) and OOT (Out of Trend) cases. Skilled in managing deviations, preparing and presenting QMS trend reports, and conducting Quality System Management Reviews. Proficient in document control and ensuring compliance with regulatory and organizational quality standards.
- Handling investigations, root cause analysis using structured problem-solving methodologies such as 5 Whys and Fishbone Analysis, brain storming sessions, conducting interviews . Coordinated cross-functional teams to gather evidence, assess impact, and develop effective corrective and preventive actions (CAPA) to eliminate recurrence
- Handling document cell, including document preparation, review, approval, distribution, archival, and life cycle management.
- Training cell management, overseeing the training program at the factory, providing scheduled training, and coordinating various external training programs. Ensuring competency assessment, on-the-job training, etc.
- Overseeing the stability and control sample management, which includes reviewing the stability planner, stability protocols, evaluation of stability trends, stability charging, and expiry management of control samples.
- Audit management, overseeing, and coordination for audit compliance. Conducting self-inspections and recommending plans for continuous improvement.
- Handled and actively participated in various audits, like EUGMP, ANVISA (Brazil), CDSCO, WHO, local FDA, Russia, Ukraine, and various customer audits.
Quality Assurance Sr. Executive
Lupin Limited
Boisar
10.2018 - 10.2023
- Handling Investigations related to OOS/OOT/Deviations/Market complaints/Extraneous peaks.
- Investigating and resolving quality-related issues, facilitating corrective and preventive actions (CAPA), and documenting findings to maintain regulatory compliance, and improve operational efficiency.
- Developing and implementing quality assurance protocols, including standard operating procedures (SOPs), to enhance product quality and safety.
- Analytical review of specifications, batch records, and analytical method validation, analytical method transfers, pharmacopeial method verification, out-of-calibration records, stability summary review, and conducting lab rounds to ensure compliance with good laboratory practices and adherence to SOPs.
- Audit coordination and participation in USFDA, TGA, WHO, CDSCO, local FDA and various customer audits.
Pharmacist
Supercare Pharmacy
Dubai
04.2014 - 04.2018
- Managing drug inventory levels, expiry management, dispensing of medications, patient counseling, handling controlled medications, training new staff, administrative and operational activities, including insurance handling, and excellent customer service.
- Providing expert pharmaceutical care by accurately dispensing medications, counseling patients on proper usage, and monitoring for potential issues, drug interactions, and side effects.
Quality Assurance Officer
Naprod Life Sciences Pvt. Ltd
Boisar
09.2012 - 04.2014
- Preparation of Batch manufacturing and batch packing documents, handling various Batch related activities.
- Handling Quality management system including Change management system, deviations, CAPA management
- Vendor management system
- Process validation programme including preparation and review of protocols and reports.
- Review and approval of artworks and shadecards
- Preparation and execution of reconstitution studies.
Quality Assurance Officer
Naprod Life Sciences Pvt. Ltd
Boisar
10.2009 - 09.2010
- Preparation and review of process validation protocols and reports
- Preparation of APQR to assess product quality throughout the life cycle
- Preparation and review of Batch manufacturing and packaging records
- Actively participated in various audits and coordinating with CFT for meetings for daily updates.
- Review of master formula records.
- Preparation of Standard operating procedures
Education
Advanced Post Graduate Diploma in Regulatory Affairs (Formulations) -
Institute of Pharmaceutical Management
India05-2025
Master of Pharmacy - Quality Assurance
H. R. Patel Institute Of Pharmaceutical Education
Maharashtra08-2012
Bachelor of Pharmacy -
H. R. Patel Institute Of Pharmaceutical Education
Maharashtra08-2009
Skills
- MS Office (Word, Excel, Power point)
- ERP & SAP operations
- Handled various software like MasterControl, Caliber, e-DMS, Catalyst, Amplelogic, and L2LMS
- Communication
- Leadership
- Decision Making
- Teamwork
- Planning
Accomplishments
- Achieved 1st rank at the institute level and 4th rank at the university level in the final year of the Master of Pharmacy.
- Achieved top 3 rank in college and consistently ranked among the top ten university students throughout all four years of the Bachelor of Pharmacy.
Personal Information
- Date of Birth: 04/29/88
- Nationality: Indian
- Marital Status: Married
- Religion: Hindu
Languages
- Hindi
- English
- Marathi
- Kannada
- Tulu
- Gujarati
Affiliations
-Completed 6 months M. pharm project training at FDC Ltd., Jogeshwari
-Worked on development and validation of in-vitro dissolution method for a multicomponent oral dosage formulation at FDC Ltd., Jogeshwari
Worked on development and validation of simultaneous estimation and dissolution assessment of Rabeprazole sodium and Levosulpiride in combined dosage form.
-Research article on “Applications of simultaneous equation method and derivative method for the determination of rabeprazole sodium and levosulpiride in pharmaceutical dosage form and dissolution samples” published in Journal of the Association of Arab Universities for Basic and Applied Sciences.
Timeline
Assistant Manager Quality Assurance
Naprod Life Sciences Pvt. Ltd
10.2023 - Current
Quality Assurance Sr. Executive
Lupin Limited
10.2018 - 10.2023
Pharmacist
Supercare Pharmacy
04.2014 - 04.2018
Quality Assurance Officer
Naprod Life Sciences Pvt. Ltd
09.2012 - 04.2014
Quality Assurance Officer
Naprod Life Sciences Pvt. Ltd
10.2009 - 09.2010
Advanced Post Graduate Diploma in Regulatory Affairs (Formulations) -
Institute of Pharmaceutical Management
Master of Pharmacy - Quality Assurance
H. R. Patel Institute Of Pharmaceutical Education
Bachelor of Pharmacy -
H. R. Patel Institute Of Pharmaceutical Education