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    Sr. Ecompliance Specialist

    Novartis
    4-10 years
    Not Disclosed
    Hyderabad India
    10 Feb. 7, 2025
    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

    Senior eCompliance Specialist (Job Description)

    Role Summary:

    The Senior eCompliance Specialist is responsible for providing Quality Assurance oversight and guidance related to Computerized Systems Validation (CSV). This role ensures compliance with regulatory requirements (such as GxP, 21CFR11) and adheres to the Novartis Quality Manual and global procedures. The specialist will manage and oversee GxP impacted changes, periodic reviews, deviations, and other operational support for GxP-regulated computerized systems.

    Key Responsibilities:

    1. Quality Oversight and Support:

      • Provide quality oversight of GxP systems, including changes, periodic reviews, deviations, etc.
      • Support compliance with Novartis and regulatory requirements for GxP-regulated computerized systems.
      • Serve as the point of contact for all CSV-related matters for GxP systems.
      • Act as an interface between IT and Business for eCompliance topics related to GxP systems.

    2. Document Review and Approval:

      • Review and approve project-related documents for GxP-relevant systems.
      • Determine GxP applicability for both GxP and non-GxP systems.
      • Review and approve deviations and ensure appropriate corrective and preventive actions (CAPA) are implemented.

    3. Operational Support:

      • Establish a trusted partnership with IT functions and provide day-to-day operational support.
      • Contribute to the preparation and execution of Validation Master Plans (VMP).
      • Review and approve periodic review reports for GxP systems and manage gaps within the CAPA management system.

    4. Supplier and Audit Management:

      • Perform supplier qualification assessments.
      • Provide audit support and assist with CAPA management.

    Essential Requirements:

    • GxP-regulated computerized systems are developed, implemented, and maintained according to Novartis requirements.
    • Timely review and approval of changes, deviations, and periodic review reports.
    • Ensure documentation supporting eCompliance and CSV requirements is up-to-date and audit-ready.
    • Proactively identify and escalate gaps in eCompliance and CSV activities.
    • Maintain client and stakeholder satisfaction through quality support.

    Desirable Requirements:

    • 5-10 years of overall experience, with at least 4 years in regulated functions like IT Quality and Compliance in the Pharmaceutical Industry.
    • Strong understanding of global regulations and Health Authority expectations (e.g., CSV, Part 11).
    • Experience with the development, implementation, and lifecycle management of computerized systems in regulated environments.
    • Experience managing GxP solutions and related technologies.
    • Familiarity with GxP supplier qualification activities.
    • Knowledge of industry best practices (ITIL, ITSM, etc.).
    • Successful cross-functional and international collaboration experience.
    • Ability to manage multiple priorities and shifting demands while maintaining a positive work attitude.
    • Strong interpersonal skills, including the ability to present to management and influence without hierarchical authority.

    Core Competencies:

    • Excellent communication, negotiation, facilitation, and interpersonal skills.
    • Ability to build trusted partnerships and influence key stakeholders.
    • Strong project initiation and delivery experience.
    • Self-starter with a commitment to quality and continuous improvement.

    Commitment to Diversity and Inclusion:

    Novartis is committed to fostering an inclusive work environment and building diverse teams representative of the patients and communities it serves.

    Accessibility and Accommodation:

    Novartis provides reasonable accommodation to individuals with disabilities. If accommodation is needed for any part of the recruitment process or for job functions, please email diversityandincl.india@novartis.com with the nature of your request.

    Why Novartis:

    At Novartis, we believe in the power of community to create breakthroughs that change patients' lives. Join us in creating a brighter future.

    Join the Novartis Network:

    Not the right role? Join our talent community to stay connected and explore future career opportunities: Novartis Talent Network

    Benefits and Rewards:

    Read our benefits and rewards handbook to learn more about how Novartis supports your personal and professional growth: Novartis Benefits & Rewards

    Job Details:

    • Division: Operations
    • Business Unit: Innovative Medicines
    • Location: Hyderabad, India
    • Company/Legal Entity: Novartis Healthcare Private Limited
    • Functional Area: Quality
    • Job Type: Full-time
    • Employment Type: Regular
    • Shift Work: No

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