Upasna Dubey
Regulatory Specialist
Birżebbuġa,Malta
Summary
Proficient in current GMP regulations, standards, and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.
Overview
3
3
years of professional experience
8
8
years of post-secondary education
3
3
Certifications
2
2
Languages
Work History
Regulatory Specialist
PharOS MT
Halfar, Malta. , Malta
04.2024 - Current
- Prepare, review, and submit regulatory filings to health authorities (FDA, EMA, etc.) for new product registrations, variations, and renewals.
- Maintain accurate and up-to-date regulatory documentation, including technical files, dossiers, and registration certificates.
- Provide regulatory guidance and support to Quality Assurance teams during audits and inspections.
- Ensure compliance of product labeling and packaging materials with regulatory requirements.
- Collaborate with R&D, Manufacturing, Quality Control, and Marketing teams to support product development and lifecycle management.
Quality Assurance Officer
Aurobindo Pharma
Halfar, Malta. , Malta
01.2022 - 03.2024
- Reviewed batch records and documentation to ensure product release criteria are met before distribution.
- Led QA activities ensuring compliance with GMP, EMA, and other regulatory requirements.
- Implemented and maintained QMS, including SOPs, change controls, and document management.
- Assisted internal audits, identifying areas for improvement and ensuring CAPA implementation.
- Managed investigations into deviations and non-conformances, ensuring effective root cause analysis and resolution.
- Collaborated with cross-functional teams to support product development, validation, and regulatory submissions.
Quality Control Analyst
Aurobindo Pharma
Halfar, Malta. , Malta
11.2021 - 01.2022
- Perform routine and non-routine analysis of raw materials and finished products using HPLC, GC, and UV-Vis spectroscopy.
- Ensure compliance with GMP and company procedures through thorough documentation and adherence to SOPs.
- Maintain and calibrate laboratory equipment according to established schedules and procedures.
- Collaborate with cross-functional teams to investigate OOS and implement effective CAPA.
- Document and report test results in LIMS accurately, ensuring compliance with GMP and company standards.
- Improved overall production efficiency by identifying and resolving quality control issues.
Education
Master of Science - Food Health And Environment (Class:Biology)
Universita Del Piemonte Orientale
Vercelli, Italy 10.2019 - 06.2022
Master of Science - Chemistry Honours
Motilal Vigyan Mahavidhyalay
Bhopal 07.2017 - 06.2019
Bachelor of Science - Chemistry Honours
Institute of Excellence in Higher Education
Bhopal 06.2014 - 07.2017
Skills
Good Manufacturing Practice (GMP)
Quality Compliance
Quality Management Systems (QMS)
Deviations and CAPA's
Oracle
Tracelink
Change Control Management
Regulatory Compliance (GMP, EMA, etc)
Risk Assessment & Management
Cross-functional Team Leadership
Pharmaceutical regulations
Certification
Health & safety at workplace
Timeline
IT cyber security
06-2024
Regulatory Specialist
PharOS MT
04.2024 - Current
Quality Assurance Officer
Aurobindo Pharma
01.2022 - 03.2024
Quality Control Analyst
Aurobindo Pharma
11.2021 - 01.2022
Health & safety at workplace
11-2020
Digital Reverse mentor
04-2020
Master of Science - Food Health And Environment (Class:Biology)
Universita Del Piemonte Orientale
10.2019 - 06.2022
Master of Science - Chemistry Honours
Motilal Vigyan Mahavidhyalay
07.2017 - 06.2019
Bachelor of Science - Chemistry Honours
Institute of Excellence in Higher Education
06.2014 - 07.2017