- 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
- 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
- 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
- Create training materials and assist in conducting training sessions for regulatory users and business stakeholders
- Ensure smooth user onboarding and promote effective system adoption
- 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
- Bachelor's degree
- 2 to 6 years of relevant experience
- 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
- 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)
- SAFe for Teams certification (preferred)
- 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
- 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.
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Associate Systems Analyst - Hyderabad / Secunderabad, Telangana - Amgen Technology Private Limited
Description
Key Responsibilities
Implementation & System Support
Validation & Compliance
System Integration & Change Management
Training & Adoption
Operations & Issue Resolution
Qualifications
Basic Qualifications
Must-Have Skills
Good-to-Have Skills
Professional Certifications
Soft Skills
Shift Information
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