Bibek Kumar Hamal Radhe
Montreal,QC
Summary
Pharmaceutical quality expert with 10 years of experience in batch release, documentation review, and regulatory compliance. Proficient in SAP, QMS, and document management systems. Dedicated to ensuring product quality through meticulous attention to detail and continuous improvement.
Overview
11
11
years of professional experience
Work History
Specialist, Quality Investigations
Jubilant Draximage
Montreal, Quebec
05.2023 - Current
- Conduct meticulous reviews and approvals of batch manufacturing and packaging records, ensuring strict adherence to specifications and marketing authorizations.
- Perform comprehensive investigations for deviations, OOS, OOT, and market complaints, authoring detailed investigation reports with well-supported conclusions.
- Audit regulatory pre-submission documents from manufacturing and quality units within the purview of ODR checklists.
- Communicate audit comments, observations, and findings to relevant stakeholders, assessing the appropriateness of responses.
- Report all audit findings in ODR audit worksheets and highlight noteworthy/major/critical observations on CDRO certifications.
- Complete audit tasks within the specified timeframe without compromising quality and archive all documents in a closed electronic system.
Quality Documentation Specialist
Novartis Healthcare Ltd
Hyderabad, Telangana
06.2021 - 01.2023
- Authored, reviewed, and revised GxP documents, including SOPs, qualification reports, and technical investigations, driving documentation excellence.
- Facilitated document review and approval processes, coordinating with multiple stakeholders to ensure timely and compliant documentation.
- Managed change requests and document change orders (DCOs) to maintain document integrity and version control.
- Supported CAPA management, tracking and trending data to drive process enhancements and present findings during management reviews.
Quality Assurance Specialist
Hetero Labs Ltd
Hyderabad, India
08.2014 - 04.2022
- Performed in-depth batch record reviews, authorizing or rejecting batches based on rigorous quality standards and established protocols.
- Oversaw deviation, change control, complaint, and CAPA management processes, proactively mitigating risks and preventing recurrence of issues.
- Conducted periodic GMP inspections, meticulously verifying compliance with cleaning, sanitation, and pest control procedures.
- Drafted, reviewed, and implemented SOPs, ensuring alignment with evolving regulatory requirements and best practices.
- Delivered comprehensive training to GMP staff, maintaining up-to-date training records and facilitating seamless onboarding of new procedures.
- Calibrated, validated or maintained laboratory equipment.
Education
Master of Science - Industrial Pharmacy
Jawahar Lal Nehru Technological University
Hyderabad,India06-2014
Skills
- Profound expertise in Pharmaceutical Quality Assurance, Quality Compliance, and Quality Systems
- Thorough understanding of cGMP, cGLP, USFDA, Health Canada, and TGA regulations
- Skilled in auditing regulatory pre-submission documents and adhering to ODR checklists
- Experience in identifying and reporting critical data integrity issues to senior management
- Proficient in SAP transactions, batch release processes, and packaging authorizations
- Expertise in root cause analysis and problem-solving tools (FMEA, 6M, 5WHY)
- Skilled in Quality Management Systems (Caliber QAMS, Trackwise) and Document Management Systems
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)
Timeline
Specialist, Quality Investigations
Jubilant Draximage
05.2023 - Current
Quality Documentation Specialist
Novartis Healthcare Ltd
06.2021 - 01.2023
Quality Assurance Specialist
Hetero Labs Ltd
08.2014 - 04.2022
Master of Science - Industrial Pharmacy
Jawahar Lal Nehru Technological University
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