5 21Cfr11 Jobs

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5.0 - 9.0 years

0 Lacs

chennai, tamil nadu

On-site

As a Senior Clinical Data Manager I at Allucent, your role involves leading data management activities in the Allucent Data Management (DM) department. You will be responsible for managing, coordinating, reviewing, and approving DM deliverables from database design & set-up to database locking. It is crucial to ensure the completeness, accuracy, and consistency of clinical data to meet quality standards and regulatory requirements for analysis and reporting. Additionally, you will provide expertise in relevant data management areas, participate in cross-functional initiatives, and contribute to the development of departmental processes, tools, and staff training. Your involvement in Request ...

Posted 1 day ago

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7.0 - 15.0 years

0 Lacs

hyderabad, telangana

On-site

Role Overview: As the eCompliance Manager at Novartis Healthcare Private Limited, your primary responsibility is to provide Quality Assurance oversight and guidance regarding computerized systems validation (CSV) within the framework of regulations such as GxP, 21CFR11, etc., as well as the requirements defined in the Novartis Quality Manual and global procedures. You will be involved in approving GxP impacted changes, Periodic Review Reports, deviations, and providing guidance on CSV-related topics to the project and operations team. Additionally, you will review and approve global Computerized Systems key validation deliverables as part of the eCompliance support to GxP projects. Key Respo...

Posted 1 month ago

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10.0 - 12.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Job Description : YASH Technologies is a leading technology integrator specializing in helping clients reimagine operating models, enhance competitiveness, optimize costs, foster exceptional stakeholder experiences, and drive business transformation. At YASH, we're a cluster of the brightest stars working with cutting-edge technologies. Our purpose is anchored in a single truth - bringing real positive changes in an increasingly virtual world and it drives us beyond generational gaps and disruptions of the future. We are looking forward to hire.NET C# Professionals in the following areas : Job Description: Experience required: 10+ years Job purpose: To design, develop and maintain software a...

Posted 1 month ago

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7.0 - 11.0 years

0 Lacs

karnataka

On-site

In your role as a Senior Clinical Data Manager I at Allucent, you will be responsible for leading data management activities within the Allucent Data Management department. Your tasks will include: - Serving as the primary contact for data management with relevant internal and external parties. - Planning and projecting required resources, managing tasks, timelines, risks, and quality. - Monitoring tasks, budgets, forecasts, and managing changes in scope, budget, and revenue recognition. - Developing, reviewing, and maintaining project-specific data management documents throughout the project lifecycle. - Leading and coordinating the development of clinical study database set-up and eCRF des...

Posted 1 month ago

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3.0 - 5.0 years

4 - 7 Lacs

ahmedabad

Work from Office

Bachelors degree in information technology, Computer Science, Engineering, or a related field. Minimum 3-5 years of experience in IT administration, preferably within a manufacturing or industrial environment. Strong knowledge of manufacturing IT systems such as MES, ERP, SCADA, PLCs, and industrial network protocols (e.g., OPC, Modbus, Profibus). Strong Knowledge of CSV Qualification documentation. Strong Knowledge of Regulatory guild line like 21CFR11, GAMP5, EU Annex11. Must know about CSV document work flow. Experience with database management, data analytics, and reporting tools. Familiarity with cybersecurity practices relevant to manufacturing environments (e.g., ICS/SCADA security, N...

Posted Date not available

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