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Global System Integration Expert, Global Dqc Coe

10+ years
Not Disclosed
10 Nov. 28, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Global System Integration Expert, Global DQC CoE

Location: Hyderabad, India
Job ID: REQ-10027504
Division: Operations
Business Unit: Innovative Medicines
Company: Novartis Healthcare Private Limited
Functional Area: Quality
Employment Type: Full-time, Regular


About the Role

The Global System Integration Expert leads efforts to create and manage system integrations using the TetraScience Data Platform to support laboratory operations. The role involves pipeline development, coding in DataWeave, and maintaining global system documentation to align with cGMP standards and organizational goals.


Key Responsibilities

  • Technical Development:

    • Act as the technical expert for DataWeave programming, creating custom pipelines for data transfer from various lab systems to LIMS.
    • Support application development stages, from planning to execution, ensuring timely completion.
  • System Integration:

    • Design and maintain systems to meet laboratory and organizational requirements.
    • Identify needs, prioritize backlog items, and ensure features align with business goals.
  • Documentation & Compliance:

    • Develop and maintain global documentation, including SOPsWIs, and user guides.
    • Ensure compliance with cGMP standards, regulatory guidelines, and Novartis quality policies.
  • Operational Oversight:

    • Support business screening, PQ scripting, and execution.
    • Provide periodic progress reports, milestone updates, and program communications.
  • Quality Strategy:

    • Contribute to Laboratory Operations Quality System strategy and implementation.
    • Drive continuous improvements in system integrations and lab data management processes.

Key Performance Indicators

  • Achievement of quality, time, and cost objectives.
  • Timely project completion based on predefined metrics.
  • Successful implementation of systems aligned with departmental goals and program plans.

Minimum Requirements

Education

  • University degree in PharmacyEngineeringChemistry, or an equivalent discipline.

Experience and Skills

  • 10+ years of laboratory experience in the pharma industry.
  • Proficiency in DataWeave programming for pipeline creation.
  • Knowledge of cGMP requirements, regulatory compliance, and Computer System Validation (CSV).
  • Familiarity with LabWare LIMS and TetraScience Data Platform.
  • Expertise in laboratory business processes and risk management tools.
  • Strong project management and cross-functional collaboration skills.
  • Proven leadership abilities and decision-making expertise.

Why Novartis?

At Novartis, innovation and collaboration drive the mission to reimagine medicine and improve lives globally. Join a passionate community to create breakthroughs that make a real difference.

Benefits and Rewards

Explore Novartis' comprehensive benefits and rewards tailored to your personal and professional growth: Benefits & Rewards Handbook.

Join the Novartis Network

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