Associate Systems Analyst - Hyderabad / Secunderabad, Telangana - Amgen Technology Private Limited

    Amgen Technology Private Limited
    Amgen Technology Private Limited Hyderabad / Secunderabad, Telangana

    16 hours ago

    Full time ₹400,000 - ₹900,000 (INR) per year *
    Description

    Key Responsibilities

    Implementation & System Support

    • Assist in implementing and supporting the Lorenz DocuBridge Suite
    • Ensure compliance with regulatory requirements (eCTD, NeeS)
    • Collaborate with Regulatory Affairs, QA, IT Security, and vendors to gather and translate business requirements into scalable solutions
    • Support project execution across all lifecycle phases: assessment, configuration, validation, launch, and post-production

    Validation & Compliance

    • Develop validation deliverables (validation plans, IQ/OQ/PQ protocols) as per GxP and 21 CFR Part 11
    • Maintain audit trail configurations, user access controls, and role-based privileges to ensure system security and compliance

    System Integration & Change Management

    • Support structured document workflows and integrate the solution with Regulatory Veeva RIM
    • Contribute to the change control process following ITIL standards, ensuring traceability of updates and patches

    Training & Adoption

    • Create training materials and assist in conducting training sessions for regulatory users and business stakeholders
    • Ensure smooth user onboarding and promote effective system adoption

    Operations & Issue Resolution

    • Monitor system performance and coordinate with business and vendor teams to resolve production issues promptly
    • Ensure minimal disruption to business continuity and timely incident resolution

    Qualifications

    Basic Qualifications

    • Bachelor's degree
    • 2 to 6 years of relevant experience

    Must-Have Skills

    • Ability to manage multiple activities and priorities independently in a fast-paced environment
    • Familiarity with Scaled Agile Framework (SAFe) and ITIL methodologies
    • Strong knowledge of information systems and networking concepts
    • Experience working with regulatory submission tools
    • Proficient in the Systems Development Life Cycle (SDLC), including design, testing, and change control

    Good-to-Have Skills

    • Experience with relational databases (e.g. Oracle, PostgreSQL) and SQL
    • Knowledge of programming languages (Java, Python)
    • Familiarity with API integrations (MuleSoft, Databricks)
    • Exposure to AWS or other cloud services
    • Understanding of FDA 21 CFR Part 11, GxP compliance, and Computer Systems Validation
    • Knowledge of Machine Learning, Natural Language Processing (NLP), and Natural Language Generation (NLG)

    Professional Certifications

    • SAFe for Teams certification (preferred)

    Soft Skills

    • Excellent analytical and problem-solving skills with strong attention to detail
    • Ability to work effectively in global, virtual environments
    • High level of initiative and self-motivation
    • Strong communication skills and ability to influence team members
    • Flexible and adaptable in ambiguous and evolving situations

    Shift Information

    • This role may require working a later shift (second or third shift) based on business needs. Candidates must be willing to work during evening or night hours as required.
    * This salary range is an estimation made by beBee
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Associate systems analyst