Global System Integration Expert, Global DQC CoE

-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

• Act as technical expert in creation of pipelines programmed in DataWeave programming language.
• Creates pipelines (custom code) to enable data form various laboratory systems to be transferred to the current LIMS system
• Supports establishment and maintenance of global documentation related to the systems in scope
• Identifies and anticipates site needs, determines what features should be implemented, and support prioritization
• 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.
• 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.

• 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

• Critical Negotiations.
• Functional Breadth.
• Project Management.
• People Leadership.
• Collaborating across boundaries.
• Operations Management and Execution.

Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Gmp Procedures, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence