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GLIMS Developer, Global DQC CoE
10-12 years
Hyderabad / Secunderabad
1 vacancy
GLIMS Developer, Global DQC CoE
Novartis
posted 1mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
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
Work Experience:
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
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
* 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.
* 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.
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
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Hyderabad
Telangana 500081
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