Major Accountabilities :

• Act as the business system subject matter expert for the Lab Information Management Systems maintained globally by the DQC CoE: LabWare LIMS
• Identifies and anticipates site needs, determines what features should be implemented, and support prioritization of the backlog items.
• Supports establishment of release timelines, content of each release, oversee the application development stages and supports completion of each release in accordance with the approved plan.
• Identifies and anticipates site needs, determines what features should be implemented, and support prioritization of the backlog items.
• Supports continuous improvement in report templates, labels, folder templates, calculations and interfaces between the systems in scope
• Supports Business screening, PQ scripting and PQ execution.
• Supports deployment/on-boarding at new sites.
• Provides required periodic progress reports, milestone activities and communications to the program management.
• Supports establishment and maintenance of global documentation related to the systems in scope (e.g. SOPs, WIs, user guides, etc)
• Contribute to Laboratory Operations Quality System in defining and implementation of strategy and defined activities.
• Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements.

Key Performance Indicators :

• Metrics according to target
• Individual project completion
• Achieves agreed targets and objectives in terms of quality, time and cost
• Supports departmental objectives to implement systems according to overall program plans

Education:

University degree in Pharmacy, Engineering, Chemistry or equivalent Discipline

Languages:

Fluent in speaking / writing in English

Experience:

Thorough knowledge of cGMP requirements:
* Strong understanding of regulatory requirements for commercial products.
* Technical understanding of laboratory business processes and enterprise data expertise

* Experience with Labware LIMS or other similar systems, and CSV
* Strong understanding of risk assessment and risk
management fundamentals/tools.
* Team and consensus builder, with definitive and
authoritative decision-making ability.

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
Operations

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