Rupesh Yerwa (PMP)®
Hyderabad
Summary
An aspiring project management professional with 6 years of experience in Quality Assurance within the biopharma industry. I possess a strong foundation in regulatory compliance & quality management system in the biopharma sector. Recently, I earned my (PMP)® certification, equipping me with the project management skills necessary to lead complex projects and drive successful outcomes. With a deep understanding of the biopharma sector, I am eager to transition into project management, where I can apply my technical expertise, leadership abilities, and project management knowledge to deliver strategic value and support organizational goals.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Scientist (QMS)
Vimta Labs Ltd.
Hyderabad
2023.04 - Current
- Spearheaded the comprehensive management of Quality Management System (QMS) activities, overseeing deviations, change controls, Out of Specification (OOS) incidents, laboratory events, and driving robust Corrective and Preventive Actions (CAPA) to uphold stringent quality standards
- Played a pivotal role in the initiation, investigation, and closure of QMS-related activities, demonstrating proficiency in quality assurance processes to ensure the effective resolution of issues and continuous improvement.
- Contributed significantly to quality-centric tasks, including the meticulous review of Method Development and Method Validation protocols, raw data, and reports, aligning closely with industry standards for precise planning and execution.
- Led data review processes for test parameters related to biopharmaceuticals, adhering to ICH Q6B standards, emphasizing a detail-oriented approach to ensure data accuracy and compliance with quality regulations.
- Proactively engaged in the preparation and review of Standard Operating Procedures (SOPs) related to Good Laboratory Practices (GLP), underscoring a commitment to establishing and maintaining robust frameworks in line with quality management best practices.
- Directed and managed all GLP-related activities, including laboratory compliance, calibrations, and training initiatives, ensuring data integrity and reinforcing a holistic understanding of quality assurance principles, with a focus on efficiency and compliance for successful quality outcomes.
QA-Executive
Enzene Biosciences Ltd.
Pune
2021.08 - 2023.03
- Executed precise analytical raw data reviews for biosimilars, covering a spectrum of test parameters, including chromatography, microbiology, bioassay, and other analytical/physico-chemical factors, in strict adherence to ICH Q6B standards. Demonstrated meticulous attention to detail and unwavering commitment to maintaining high-quality standards.
- Led the thorough review and management of stability studies, encompassing the examination of raw data, consolidated data, stability protocols, and reports. This responsibility showcased a dedication to systematic and organized project oversight, crucial in a fast-paced organization where my contributions played a pivotal role in multiple biosimilar product launches.
- Directed Analytical Method Validation and Method Transfer processes, showcasing proficiency in navigating critical components of the analytical lifecycle and ensuring seamless transitions aligned with project management principles.
- Implemented periodic review practices for audit trails on QC equipment, emphasizing a proactive approach to quality control and the adoption of best practices in equipment management, contributing to the efficiency of rapid product development and launch cycles.
- Managed various Quality Management System (QMS) activities, including Out of Specification (OOS) incidents, deviations, change controls, and laboratory incidents. This multifaceted role highlighted my expertise in orchestrating and streamlining project-related quality processes, integral to the success of numerous biosimilar launches in a high-paced environment.
- Functioned as the QC reviewer in the Bioassay laboratory, undertaking the review of relative potency assay data, showcasing hands-on involvement in laboratory processes crucial to project success and product quality.
- Orchestrated the management of batch release activities, showcasing an ability to coordinate and oversee critical project milestones, ensuring products met quality standards before reaching the market and contributing significantly to the successful launch of multiple biosimilar products.
- Oversaw Raw/Packing material release, involving the preparation of specifications and Standard Testing Procedures (STPs), coupled with the meticulous review and authorization of Certificate of Analysis (COA). This demonstrated a holistic understanding of project requirements from raw material to finished product, essential in a fast-paced organization focused on multiple product launches.
- Successfully handled periodic self-inspections/internal audits, underscoring a commitment to continuous improvement and compliance with project management principles, ensuring a robust quality infrastructure in a dynamic and fast-paced organizational setting with a track record of contributing to multiple biosimilar product launches.
QA-Executive
DK Biopharma
Mumbai
2021.01 - 2021.07
- Established robust document control processes crucial for quality and compliance in a startup environment.
- Contributed proactively to formulating stability protocols, showcasing hands-on involvement in early-stage product development.
- Collaborated in preparing Raw Material specifications, STPs, and analytical test reports, emphasizing versatility in quality control roles for startups.
- Played a vital role in creating SOPs, laying the foundation for compliance and operational efficiency in a startup setting.
- Engaged actively in analytical data review, demonstrating a commitment to maintaining high-quality standards in a startup's dynamic environment.
- Actively participated in batch dispatch, showcasing adaptability and efficiency in navigating operational dynamics specific to startups.
QA-Executive
Intas Biopharma
Ahmedabad
2018.05 - 2020.06
- Actively engaged in meticulous QC/Analytical data reviews for biosimilars, aligning with ICH Q6B standards—a foundational commitment to industry best practices at the outset of my career.
- Played a crucial role in QMS activities, initiating and overseeing deviations, change controls, and CAPA, showcasing dedication to high standards in quality assurance processes early in my career.
- Managed compliance and batch release activities, showcasing a comprehensive understanding of critical regulatory milestones, emphasizing commitment to stringent quality criteria.
- Ensured regulatory compliance in QC laboratories, exhibiting a proactive approach to maintaining standards in a foundational quality assurance role.
- Actively contributed to the preparation and review of 'Annual Product Quality Review documents', highlighting early involvement in comprehensive quality assessments and reporting.
- Participated in the review of stability protocols, raw data, and reports, demonstrating an early commitment to detailed examination of critical project data and processes in the quality assurance domain.
- Contributed to the Qualification activity of the Laboratory Information Management System (LIMS), showcasing adaptability and hands-on experience with advanced laboratory technologies at the start of my career.
Education
Master of Science - Biotechnology
Fergusson College
Pune03.2018
Skills
Project Management
Regulatory Affairs
Quality Assurance
Quality Management system
Analytical raw data review
Analytical Method Validation/Transfer
MS-Office Tools
Certification
- Project Management Professional (PMP)® by PMI
- Certified associate in Project Management (CAPM)® by PMI.
- PG diploma in Drug Regulatory Affairs by Global Institute of Regulatory Affairs.
- CSIR - URDIP Certificate - Intellectual Property Rights.
Academic Project
- Patenting Biosimilars - A comparitive perspective of US, EU & India.
- Aimed for answering the question - Are Biosimilars Patentable?
- Performed patent search activities.
- Analyzed Patent claims of various Biosimilars.
Hobbies
- Long Distance Running
- Playing Guitar
- Reading (Non-Fiction)
- Psychology/Philosophy
Timeline
Scientist (QMS)
Vimta Labs Ltd.
2023.04 - Current
QA-Executive
Enzene Biosciences Ltd.
2021.08 - 2023.03
QA-Executive
DK Biopharma
2021.01 - 2021.07
QA-Executive
Intas Biopharma
2018.05 - 2020.06
Master of Science - Biotechnology
Fergusson College