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R&D Quality Specialist

REQ-10059152
8月 12, 2025
India

摘要

The Quality Specialist manages user access for critical applications, creates and updates training materials, authors and maintains SOPs, supports end-user onboarding, coordinates with IT for user access issues, oversees document management and archival, and owns quality processes including change controls, CAPAs, and investigations.

About the Role

Key Responsibilities:

  • Oversee user access management for designated applications, ensuring timely provisioning, modification, and deactivation in line with compliance standards. Develop, update, and maintain training materials and user guides related to application usage and quality processes.
  • Author, revise, and maintain Standard Operating Procedures (SOPs) relevant to application management and QA workflows.
  • Provide end-user support for onboarding, including training delivery and troubleshooting access or usage issues. Act as the primary liaison with IT teams to resolve user access issues and coordinate on application enhancements or changes.
  • Support and document application enhancement activities, including requirement gathering, testing, and user communication. Handle GXP document archival processes, ensuring compliance with document management procedures.
  • Troubleshoot document management issues such as document transfer failures, incorrect archival location, and naming convention errors.
  • Maintain accurate records of user access, training completion, SOP updates, and document archival for audit readiness.
  • Own and manage change controls, serving as the designated owner for quality events, CAPAs (Corrective and Preventive Actions), and investigation actions. Approve quality events and ensure timely closure of related actions.
  • Contribute to continuous improvement initiatives within the QA team and support cross-functional projects as needed.

          Minimum Requirements

  • Bachelor’s degree in Life Sciences, Computer Science, or related field.
  • 2+ years’ experience in quality, IT support, document management, or user access management roles in a regulated environment (pharma preferred).
  • Strong understanding of compliance, data integrity, document management, and quality event processes.
  • Excellent communication and collaboration skills.
  • Experience with application onboarding, training, SOP authorship, and quality event ownership is highly desirable.

Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: http://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. http://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
http://talentnetwork.novartis.com/network

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: http://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards

Development
Universal Hierarchy Node
India
Hyderabad (Office)
Quality
Full time
Regular
No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
REQ-10059152

R&D Quality Specialist

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  1. http://www.novartis.com/about/strategy/people-and-culture
  2. http://talentnetwork.novartis.com/network
  3. http://www.novartis.com/careers/benefits-rewards
  4. http://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Hyderabad-Office/R-D-Quality-Specialist_REQ-10059152-1
  5. mailto:[email protected]
  6. http://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Hyderabad-Office/R-D-Quality-Specialist_REQ-10059152-1