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    Analyst – Quality Operations

    Novartis
    3-5 years
    Not Disclosed
    Hyderabad
    10 Nov. 27, 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

    Analyst – Quality Operations

    Location: Hyderabad, India
    Job ID: REQ-10030263
    Company: Novartis Healthcare Private Limited
    Division: Operations
    Business Unit: Innovative Medicines
    Functional Area: Quality
    Job Type: Full-time

    About the Role

    The Analyst – Quality Operations is responsible for delivering quality services in compliance with cGMPrequirements and the Novartis Quality Management System. This role involves managing regulatory workflows and ensuring product quality compliance through various quality assurance activities.

    Key Responsibilities

    • Quality Operations Services:

      • Perform and deliver services that support product quality compliance and regulatory workflows.
      • Hold accounts in workflow applications like SAP, Dragon, and SUBWAY to ensure service deliverables.

    • Stability Management & QC Release:

      • Support Stability management (drafting reports, performing temperature excursion assessments, risk assessments).
      • Support QC release activities (creating, modifying, and reviewing inspection plans, inspection lot numbers, and certificates of analysis and compliance).

    • Testing Monograph Management & Risk Evaluation:

      • Author and manage testing monographs, perform impact assessments, and handle risk evaluations for Nitrosamines.
      • Perform authoring activities using Subway software and collect data for weekly meetings and project updates.

    • Statistical Support & Performance Trending:

      • Provide statistical support and analyze performance trends to drive business decisions.

    • Compliance and Audit Support:

      • Ensure compliance with Novartis internal quality standards, regulatory requirements, and service level agreements.
      • Actively support during internal and external audits.
      • Adhere to current GxP and compliance policies.

    Key Performance Indicators

    • On-time and GMP-compliant release of dosage forms.
    • No complaints from authorities regarding inspections within the area of responsibility.
    • Successful support for continuous improvement projects.

    Minimum Requirements

    • Education: Pharmacy, Science, MBA, Engineering, or equivalent from a reputed institute.
    • Experience: Minimum 3 years in Quality Assurance, Regulatory, or manufacturing of pharmaceutical drug substances/products/medical devices.
    • Skills:
      • Knowledge of GxP, basic IT skills.
      • Strong communication, presentation, and interpersonal skills.
      • Experience working with global stakeholders.
      • Continuous learning and adaptability.

    Why Novartis?

    Novartis is committed to transforming medicine to improve lives. The company thrives on collaboration, supporting smart, passionate people to drive breakthroughs that change patients’ lives.

    Benefits and Rewards

    Explore the full range of benefits in the Novartis Life Handbook: Novartis Life Handbook.

    Join the Novartis Network

    If this role isn't a match for your skills, but you'd like to stay informed about future opportunities, join the Novartis Talent Network: Novartis Talent Network.

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