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Associate Systems Analyst - docuBridge

ConfidentialHyderabad / Secunderabad, Telangana

30+ days ago

Job 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.

Skills Required

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Associate Analyst • Hyderabad / Secunderabad, Telangana

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