Roma Bhalerao
Boston,MA
Summary
Results-driven student of an MS in Regulatory Affairs from Northeastern University. Extensive experience of over 7 years in analytical R&D and quality assurance in the pharmaceutical industry, including a successful 6-month internship in quality assurance. Highly motivated with a strong ability to navigate complex regulations, ensure compliance, and offer valuable support for regulatory submissions. Known for exceptional attention to detail, strong analytical skills, and goal-oriented communication abilities.
Overview
7
7
years of professional experience
Work History
Quality Associate Co-Op
EnGene Inc.
01.2023 - 07.2023
- Reviewed and evaluated 16 Batch Production Records (BPCR) and modified 3 Master Batch Records (MBR) for compliance and accuracy.
- Developed 10+ comprehensive Corrective and Preventive Actions (CAPA) plans for timely resolution and effective measures.
- Communicated effectively with cross-functional teams and vendors during successful phase transition in large molecule lifecycle by maintaining quality assurance throughout the process.
Sr. Executive, Analytical
Strides Pharma Science Ltd
09.2016 - 08.2021
- Managed and responded to analytical Regulatory Queries for formulations including Oral Solids, Topicals, and Oral Suspensions, addressing USFDA requirements.
- Supported IT teams in developing electronic raw data sheets for efficient execution of finished product, stability, and in-process analysis in quality control unit.
- Mentored and trained junior lab staff, overseeing 10+ staff and vendors.
Research Associate
Lupin Ltd
11.2015 - 09.2016
- Prepared Method Validation, Method Equivalency, and Cleaning Method Validation summary reports and submitted them to DQA (Data Quality Assurance).
- Provided substantial support in stability analysis of various formulations, including oral solids and ophthalmic solutions, within Analytical R&D (Oral Solids-Validation) department.
- Conducted validation parameters, such as Accuracy, Linearity, Specificity, Method Precision, and Intermediate Precision, for Analytical HPLC and Ultraviolet spectroscopy methods.
Research Associate
Dr. Reddy's Laboratories
08.2013 - 10.2015
- Supported analysis and filing of 505b (2) applications within Analytical R&D (Dermatology-Proprietary products) department.
- Prepared and conducted Internal Audits, ensuring compliance with current Good Laboratory Practices and Safety practices.
- Analyzed Developmental Stability Samples and generated Stability Testing Data for dermatology and OTC marketed products, employing complex troubleshooting and leading scientific problem-solving initiatives.
Education
Master of Science - Regulatory Affairs
Northeastern University
Boston12.2023
Master of Science - Analytical Chemistry
University of Pune
India06.2013
Bachelor of Science - Biochemistry
Shri Shivaji College of Arts, Science, Amravati University
India06.2011
Skills
- Regulatory: NDA, ANDA, BLA,GMP, GDP, GCP, ICH Guidelines, 21 CFR Part 210,211, CAPAs, Quality Inspection, Quality Review, Regulatory Compliance,Drug and Medical Device Safety
- Technical Skills: Strong analytical skills, HPLC, UPLC, FTIR, LIMS, Track wise, Microscope, Microsoft Word, Excel, PowerPoint, Adobe, Visio
- General skills: Exceptional attention to detail, adept project and time management skills, Communication Proficiency, Problem Solving,Conflict Resolution,Presentation Skills, Cross functional Collaboration
Certifications
· GMP Certificate (2021 to present)
· Certificate in ICH-GCP: Good Clinical Practice (2022 to present)
· FDA's Role in Post-marketing Drug Safety Surveillance (Continuing Education Certificate-2022 to present)
Timeline
Quality Associate Co-Op
EnGene Inc.
01.2023 - 07.2023
Sr. Executive, Analytical
Strides Pharma Science Ltd
09.2016 - 08.2021
Research Associate
Lupin Ltd
11.2015 - 09.2016
Research Associate
Dr. Reddy's Laboratories
08.2013 - 10.2015
Master of Science - Regulatory Affairs
Northeastern University
Master of Science - Analytical Chemistry
University of Pune
Bachelor of Science - Biochemistry
Shri Shivaji College of Arts, Science, Amravati University