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PRIYA BOLIA
Regulatory Affairs
Goregaon, Mumbai
Summary
Dedicated and driven professional seeking a challenging position in Regulatory Affairs within a reputed organization to leverage my expertise and contribute to business growth.
Overview
7
7
years of professional experience
8
8
years of post-secondary education
1
1
Certification
1
1
Language
Work History
Executive-Regulatory Affairs
Supriya Lifescience Limited
Mumbai
05.2022 - Current
- Preparing, compiling, and ensuring the submission of Drug Master Files (DMFs) and amendments to Europe, the US, Brazil, and other ROW markets
- Responding to deficiency letters from various authorities within stipulated time-frames
- Working in coordination with departments like location regulatory affairs, Quality Assurance, Quality Control, Supply Chain, Procurement, Research & Development, Project Management, and other departments to fulfill the regulatory obligations and ensure conformity with Health authority guidelines and facilitate the smooth functioning of Business development
- Reviewing technical documents (Starting Material Technical Package, Batch Production Records, Development reports, validation reports, etc.) & intimating respective departments to arrange for further necessities if required
- Taking responsibility for post-approval change submissions, including reviewing and discussing change control proposals for their impact assessment and assigning appropriate 'change category' as per USFDA guidance
- Responding to the queries raised by customers to support Business development
- Providing timely support in terms of high-quality documentation to the Marketing Department, encouraging Business Advancement
- Proficiently managing the compilation and submission of applications for NOCs, Test License NOCs, WHO-GMP certifications, COPPs, Written Confirmation Certificates, State FDA Manufacturing Licenses, and Free Sale Certificates
- Efficiently Managing the Audit Schedule
Senior Officer QA-QMS Documentation
Atlas Lifesciences Pvt. Ltd.
Ahmedabad
06.2021 - 04.2022
- Prepared and reviewed Annual Product Quality Review (APQR) documents, ensuring compliance with industry standards and regulatory requirements.
- Led process validation initiatives, employing comprehensive analysis and validation protocols to enhance the efficiency and reliability of manufacturing processes, contributing to the overall quality improvement.
- Actively participated in Quality Management System (QMS) activities, focusing on Change Management processes etc.
- Demonstrated proficiency in managing deviations and Corrective and Preventive Actions (CAPA), showcasing problem-solving skills and proactive measures to address quality-related challenges.
- Exhibited meticulous attention to detail in maintaining accurate and organized documentation, aligning with regulatory requirements and company policies, ensuring a streamlined and compliant workflow.
Quality Assurance
Pellucid Lifesciences. Pvt. Ltd
Ahmedabad
10.2016 - Current
- Managed Documentation
- Conducted Internal Audits
- Successfully faced audits for HACCP/cGMP, FSSC22000, Halal, Kosher, SMETA (2016-2021).
- Oversaw Records and Certificates
- Analyzed Information and Promoted Process Improvement
- Issued Production-related Documents such as BMR. COA, Change control etc
- Managed Raw Material Clearance and Finished Goods Release
- Handled Laboratory Management
- Qualified Vendors
- Demonstrated expertise in microbiology, including activities such as media preparation, sterilization, inoculation, fermentation, and related tasks
Education
Master of Science - Biotechnology
University of Rajasthan, Dr. B. Lal Institute of Biotechnology
Jaipur 07.2013 - 06.2015
Bachelor of Science - Biotechnology
MLSU
Udaipur 07.2010 - 06.2013
Intermediate -
Jawahar Navodaya Vidyalaya
Rajasamand 07.2008 - 07.2010
Matriculation -
Jawahar Navodaya Vidyalaya
Rajasmand 07.2007 - 07.2008
Skills
Experience working in Analytical/Research & Development Labsundefined
Certification
Completed a 6-month Regulatory Affairs course on Global Regulatory Affairs
Interests
Timeline
Completed a 6-month Regulatory Affairs course on Global Regulatory Affairs
07-2023
Executive-Regulatory Affairs
Supriya Lifescience Limited
05.2022 - Current
Senior Officer QA-QMS Documentation
Atlas Lifesciences Pvt. Ltd.
06.2021 - 04.2022
Quality Assurance
Pellucid Lifesciences. Pvt. Ltd
10.2016 - Current
Master of Science - Biotechnology
University of Rajasthan, Dr. B. Lal Institute of Biotechnology
07.2013 - 06.2015
Bachelor of Science - Biotechnology
MLSU
07.2010 - 06.2013
Intermediate -
Jawahar Navodaya Vidyalaya
07.2008 - 07.2010
Matriculation -
Jawahar Navodaya Vidyalaya
07.2007 - 07.2008
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