Summary
-Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures
About the Role
Job Purpose:
The Global Lab Information Management Systems Expert supports the efforts to develop and enhance data management systems managed by the Global DQC CoE and is responsible under the lead of the Global Lab Information Management Systems Lead for development, enhancement and maintenance of these systems to meet the needs of the organization and maximizes the value creation of the applications
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Experience Required: Minimum 10 years of laboratory experience in a pharma industry.
Major Accountabilities:
- Act as the business system developer 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.
- Performs configuration of new functionalities, conducts code review and supports business screening, PQ scripting and PQ execution.
- 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.
- 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
Minimum Requirements:
Education:
University degree in Pharmacy, Engineering, Chemistry or equivalent Discipline
Work Experience:
Experience:
Thorough knowledge of cGMP requirements:
* Computer System Validation experience is key expectation, similarly coding experience
* 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
* Strong understanding of risk assessment and risk
management fundamentals/tools.
* Team and consensus builder, with definitive and
authoritative decision-making ability.
- Critical Negotiations.
- Functional Breadth.
- Project Management.
- People Leadership.
- Collaborating across boundaries.
- Operations Management and Execution.
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