Manawwar Roshan
QA-CSV Manager at Lantheus | Somerset, New Jersey, United States
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As the QA-CSV Manager at Lantheus, Manawwar Roshan plays a pivotal role in ensuring the integrity and compliance of computerized systems within the organization. With over 15 years of extensive experience in Quality Assurance and Computer Systems Validation (CSV), Manawwar is adept at navigating the complexities of IT Lifecycle Management, particularly in regulated environments. His expertise encompasses critical areas such as GxP compliance, 21 CFR Part 11, EU Annex 11, and GAMP5, which are essential for maintaining data integrity and ensuring that systems meet stringent regulatory requirements.
In his current role, Manawwar is responsible for providing comprehensive quality oversight for IT systems and applications that support various functions across Lantheus, including Manufacturing, Regulatory Affairs, Technical Operations, and Clinical Development. He collaborates closely with the IT-CSV team to implement a risk-based CSV process throughout the IT System Lifecycle, ensuring that software quality is maintained from development through deployment and beyond. His proactive approach to IT audits and compliance not only safeguards the organization against potential risks but also fosters a culture of continuous improvement.
Manawwar's skill set is further enhanced by his proficiency in SDLC documentation development, project management, and consultancy services. He is well-versed in industry-leading tools such as Documentum and Veeva Vault, and utilizes HP Application Lifecycle Management to streamline processes and improve efficiency. By leveraging his extensive knowledge and experience, Manawwar Roshan continues to drive quality assurance initiatives that align with Lantheus's commitment to delivering safe and effective healthcare solutions.
QA-CSV Manager at Lantheus in November 2023 to Present
Principal QA Consultant at Lantheus in June 2023 to October 2023
Independent Consultant at Independent Consultant in February 2018 to February 2023
Sr. QA / Test Manager at Johnson & Johnson in June 2017 to October 2017
Principal Consultant / CoE Lead – Life Sciences at CGI in April 2006 to May 2017
Computer Systems Validation Engineer at QPharma, Inc. in March 2003 to December 2004
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SDLC Documentation development training
GAMP v5
Quality Assurance & Compliance
Computer System Validation
Risk based Frameworks
Open Text ALM
Manufacturing IT Systems
TrackWise
Documentum
SharePoint Workflow
Veeva Vault
Electronic Lab Notebooks
Grants Management
SAP Implementation
GAMP5
21 CFR 820
Quality Systems Regulation
CSV Center of Excellence
Project Management
Project Estimation
Resource Management
Model-N
Test Planning
SharePoint
Project Planning
U.S. Title 21 CFR Part 11 Regulation
Data Integrity
Software Development Life Cycle (SDLC)
Agile & Waterfall Methodologies
HP Application Lifecycle Management
Jira
Consultancy Services
Quality Management
Google Cloud Platform (GCP)
Operational Excellence
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Discover more about LantheusWhat is Manawwar Roshan email address?
Email Manawwar Roshan at [email protected] and [email protected]. This email is the most updated Manawwar Roshan email found in 2026.
How to contact Manawwar Roshan?
To contact Manawwar Roshan send an email to [email protected] or [email protected]. (updated on October 31, 2024)
What company does Manawwar Roshan work for?
Manawwar Roshan works for Lantheus
What is Manawwar Roshan's role at Lantheus?
Manawwar Roshan is QA-CSV Manager
What is Manawwar Roshan's Phone Number?
Manawwar Roshan's phone (201) ***-*387
What industry does Manawwar Roshan work in?
Manawwar Roshan works in the Pharmaceutical Manufacturing industry.
Manawwar Roshan Email Addresses
Manawwar Roshan Phone Numbers
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