Labeling Jobs in Hyderabad

3 Jobs Found

NO

Clinical Trial Supply Manager

Novartis

3-4 Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Summary We are Novartis. Join us and help us reimagine medicine. • Novartis mission: At Novartis, we reimagine medicines to improve and extend people’s lives.• Global Clinical Supply Vision: To become an intelligent, agile organization to deliver more products to more patients more efficiently through empowered and highly capable Global Clinical Supply teams. • Clinical Trial Supply Manager Vision: Be a trusted business partner by designing & delivering clinical supplies to serve our patients with excellenceAbout the RoleHSEMajor accountabilities: • CTSM will be responsible for study supply leadership to ensure timely planning and execution of supply strategy for continued supply of clinical finished goods (supply drugs) to patients. • Study managers provides inputs in clinical study protocol, understand study design and are responsible for optimal clinical trial supply strategy in terms of packaging design and pro-active planning following a risk-based approach • Represent Global Clinical Supply as a single point of contact (SPOC) at trial level for the integrated Clinical Trial team (iCTT).·Accountability and leadership • Self awareness Open to seek and receive feedback Having Right attitude·Operational & Project excellence • Proactive in study planning and assigned portfolio • Ensures to have robust risk management (identification and mitigation of risks) and various scenarios to support decision-making process • Able to navigate through current processes and procedures , while focusing on continuous improvement • Setting priorities and holding self and others accountable to meet commitments. ·Stakeholder management & Interpersonal skills • Able to engage, influence, align and lead internal and external business partners • Ability to work well with diverse groups of people, handle conflict & challenging situations effectively and build formal and informal relationships·Communication Skills & Business mindset • Able to communicate effectively with different audiences • Ability to consider business necessities and financial indicators when taking decisions and managing budgets. ·Managing Change • Ability to effective rebound from set-backs and adversity when facing difficult situations • Ability to adopt to different situations and to operate effectively during times of uncertainty.Minimum Requirements:Work Experience: • Functional Breadth. • Managing Crises. • People Challenges. • Collaborating across boundaries. • Operations Management and Execution. • Project Management. • 3-4 years relevant experience.Skills: • Advanced Project Management. • Supply Chain Planning. • Supply-Chain Management. • Data & Digital Savviness with high learning agility • Knowledge of relevant regulations (GMP, HSE)Languages : • English.

Clinical Supply Manager Clinical Manager Clinical trial manager
AI

Sr. Associate Regulatory Affairs

Amgen Inc

1-2 Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, post market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master s degree OR Bachelor s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms Qualification : Bachelors degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Sr. Associate Sr. associate Regulatory Regulatory associate
SA

Quality Engineer Ai Cloud- Lmts / Pmts

Salesforce

8+ Years | Not Disclosed | Hyderabad, Telangana, India | Full-time

Description Einstein products & platform democratize AI and transform the way Salesforce builds trusted machine learning and AI products - in days instead of months. It augments the Salesforce Platform with the ability to easily create, deploy, and manage Generative AI and Predictive AI applications across all clouds. We achieve this vision by providing unified, configuration-driven, and fully orchestrated machine learning APIs, customer-facing declarative interfaces and various microservices for the entire machine learning lifecycle including Data, Training, Predictions/scoring, Orchestration, Model Management, Model Storage, Experimentation etc. We are already producing over a billion predictions per day, Training 1000s of models per day along with 10s of different Large Language models, serving thousands of customers. We are enabling customers' usage of leading large language models (LLMs), both internally and externally developed, so they can leverage it in their Salesforce use cases. Along with the power of Data Cloud, this platform provides customers an unparalleled advantage for quickly integrating AI in their applications and processes. About the team: Join the AI Cloud Quality Engineering team, and become a specialist on Salesforce's AI Platform and applications! You will be a key member of the Quality Engineering team in India as we build the India organization, while working with experts worldwide. You'll get to work with latest technology in the AI space (including generative AI), and collaborate with the team and cloud to identify and run quality initiatives to support massive scale planned both in the short term and long term. We are a small, friendly team that has been working together for years - outside of quality, we focus on volunteering and other shared interests. Job description summary: As a Quality Engineer for the Salesforce AI Cloud, you will be responsible for leading the design, development and execution of comprehensive test plans/quality strategies with emphasis on automation . You will collaborate closely with product & engineering teams, actively contributing to the quality of new features while ensuring successful execution of regression tests in various environments. You will be working in a fast phased environment and will be expected to understand complex backend AI flow systems/dependencies, identifying potential risks, and strategically plan and execute comprehensive testing efforts to ensure the stability, reliability and quality of the feature and release. Skills needed for role: * Strategic and Tactical leadership : Experience leading analysis of coverage gaps and writing E2E and integration tests, partnering with teams to drive service level test coverage * Technical Expertise: Technical excellence and leadership required in identifying, developing and maintaining tests involving API, databases and web UI tests. Strong knowledge of automation tools and continuous automation systems. * Cross Team Collaboration: Ability to work with stakeholders (internal customers) from multiple organizations that leverage our central platform for custom applications. Collaborate with them to determine key shared usage patterns to prioritize test coverage of, as well as provide guidance to these customers on how to proactively test their application s integration with the platform. * Strong knowledge and experience of Java/Python/Selenium/CD pipeline configurations * Excellent communication skills: Experience generating reports, presenting and holding the quality bar for new features & release * Experience working in Global teams: Ability to work and partner with peers and other partner teams across timezones. * 8+ years of QE experience and 2+ years of experience leading projects and partnering/leading junior members of the team. Nice to have skillsets (or skillsets expect to develop in this role): * Understanding of LLM Model hosting with Sagemaker * Understanding LLM Finetuning and Inferencing * Testing integrations with Cohere, Anthropic, Dolly, Google, etc. as well as internal models * Sagemaker GroundTruth integration for data labelling, Bedrock for model serving * Experience with Azure Open AI * Experience with Tableau around creating dashboards for reporting What the team does: * Center of Excellence for Quality within the AI Platform teams, driving excellence through automation, tools, and streamlined processes (evangelizing shift left methodologies) . * Building/enhancing test frameworks/tooling for the easy creation and maintenance of integration and end-to-end tests. * Proactively drive quality by monitoring and reporting of test stability metrics for pre-prod & Prod environments through dashboards, triaging and filing and follow up of bugs. * CUJs(Critical User Journey test) for cross-cloud integration and apps * Configure tooling/runners for automated tests, used by scrum teams * Configure various test environments such as setting up core test env hawking test env connectivity * Define and measures Quality metrics (code coverage, endpoint coverage, service coverage, etc.) goals are met for the ML foundations * Automation strategies and framework support for all kinds of testing * Identify risks with releases, deployments, etc. * Support TAM expansion to multiple geographies and monitoring platform stability * Daily management of Integration tests pass rates in Test, App-Dev, Stage & Prod environments - bugs created/assigned if failures not being addressed, building test result dashboards and simplifying feedback/debugging process for engineers

Quality Engineer Quality Engineer Engineer Quality Ai

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