Summary
-Ensure and support overall GxP conformity and compliance with the Novartis Quality Manual, the law and other policies / procedures in processes like e.g. document management, change control system, training, escalation management, risk management, qualification / validation and CSV
About the Role
Global QMS RDQ Senior Specialist
About the Role:
As an experienced specialist drive efficiency and productivity gains through contributing to the implementation of new processes to administer a validated Global Learning Man-agement System (LMS) covering multiple GxP areas in full alignment with Development and QA business goals and strategic objectives.
Management of GDD GxP Training content in LMS achieving full regulatory training compliance.
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Key Responsibilities:
- Manage user accounts for global Development Global Learning Management System (LMS)
- Release training assignments in the LMS based on applicability's in STAR
- Update STAR and LMS as per LF Request (Applicability's Change Request process)
- Training systems document maintenance
- New/Remove/Update Roles in STAR and LMS
- Provide technical or administrative support for users
- Maintain access to LFRC and LFAR upon request
- Adhere to the global LMS Admin guidelines
- Ensure harmonization of LMS usage in global Development
- Perform validation activities - Validation Report, QC of releases, etc
- Brings up in a timely manner any Level 2 issues related to the LMS
- Be a role model for the Novartis values and behaviors and support the journey towards an inspired, curious, unbossed and self-aware organization
- Seek and implement opportunities for improving efficiency and effectiveness in our training system.
Essential Requirements:
- Significant relevant work experience (> 5 years) in the pharmaceutical industry or public health sector, in the area of Quality, Human Resources or Training.
- Demonstrated knowledge in implementing/managing robust Document management systems and Learning Management Systems, setting global quality controls in a regulated area
- Sound understanding of regulated activities, health authority expectations, and GxP, paired with good business understanding.
- Role model for the Novartis values and behaviours and exemplary interpersonal skills
- Excellent leadership, interpersonal, communication, negotiation and problem solving skills
- Ability to innovative when faced with opportunities or challenges.
- Ability to influence and drive/facilitate change across the organization.
Desirable Requirements:
- Bachelor/Technical degree in Life Sciences or related fields. Advanced degree and/or MBA an advantage
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: https://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. https://www.novartis.com/careers/benefits-rewards
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: https://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? https://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: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Development
Business Unit
Innovative Medicines
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No