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Glims Developer, 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

GLIMS Developer, Global DQC CoE

Location: Hyderabad, India
Job ID: REQ-10027499
Division: Operations
Business Unit: Innovative Medicines
Company: Novartis Healthcare Private Limited
Functional Area: Quality
Employment Type: Full-time, Regular

About the Role

The GLIMS Developer supports the development, enhancement, and maintenance of Lab Information Management Systems (LIMS) under the Global DQC CoE to meet organizational needs while ensuring compliance with cGMPQuality Assurance Agreements, regulatory requirements, and Novartis Quality standards.

Key Responsibilities

  • LIMS Development:

    • Act as a business system developer for LabWare LIMS globally maintained by DQC CoE.
    • Configure functionalities, review code, and manage system improvements such as templates, labels, and interfaces.
    • Support qualification activities, including PQ scripting and execution.
  • Operational Oversight:

    • Collaborate to establish release timelines and manage the content for each release.
    • Ensure adherence to approved project plans.
    • Provide regular progress reports and communications to program management.
  • Continuous Improvement:

    • Enhance system efficiency by refining report templates, labels, folder structures, and calculations.
    • Develop and maintain global system documentation, including SOPs and user guides.
  • Compliance and Quality:

    • Adhere to cGMP standards and all applicable procedures.
    • Support quality systems in defining and implementing strategies.

Key Performance Indicators

  • Achievement of agreed targets in terms of quality, time, and cost.
  • Timely project completion according to metrics and objectives.
  • Contribution to departmental goals aligned with 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.
  • Thorough knowledge of cGMP requirements and regulatory standards for commercial products.
  • Experience with LabWare LIMS or similar systems.
  • Expertise in Computer System Validation (CSV) and coding.
  • Strong understanding of laboratory business processes, enterprise data systems, risk management, and assessment tools.
  • Proven ability to lead cross-functional teams, negotiate, and collaborate effectively.
  • Proficient in project management and operations management.

Why Novartis?

At Novartis, innovation and collaboration drive the mission to reimagine medicine and improve lives globally. Join a passionate community to create a brighter future for patients.

Benefits and Rewards

Discover Novartis' comprehensive benefits and rewards designed for professional and personal growth: Benefits & Rewards Handbook.

Join the Novartis Network

Stay connected for future career opportunities: Novartis Talent Network.