Amgen

Specialist IS Business Analyst

India · On-site · Full time

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About the role

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EmployerAmgen
LocationIndia
Work styleOn-site
Employment typeFull time
Employer posted15 Sep 2026

Career Category

Information Systems

Job Description

Position Summary

Lead the validation team in a GMP High Salesforce application and serve as the accountable leader for validation governance, GxP compliance, RTM traceability, inspection readiness, and quality oversight. Drive compliant delivery through strong validation leadership, risk-based decision making, and operational excellence while developing a high-performing validation team.

Key Responsibilities

Lead validation strategy, governance, and execution for GxP-regulated applications, computerized systems, and digital platforms.
Ownership & oversight for validation activities, ensuring compliance with internal SOPs, regulatory requirements, and industry standards.
Author & ownership of validation deliverables including Validation Plans, Risk Assessments, IQ/OQ/PQ Protocols, Validation Summary Reports (VSRs), and Requirements Traceability Matrices (RTMs).
Establish and maintain end-to-end traceability between requirements, risks, test evidence, defects, and compliance documentation through RTM governance.
Ensure inspection of readiness and support internal audits, regulatory inspections, CAPA, deviation management, and change control activities.
Complete ownership of validation strategy, testing scope and end-to-end system validation.
Lead and mentor Validation Engineers, establishing best practices and driving a quality-first culture.
Partner with Product, Business, Quality, Regulatory, and Technology teams to support compliant and timely delivery of business initiatives.
Drive continuous improvement initiatives to reduce validation cycle time while maintaining compliance and quality standards.

Show full description

Basic Qualifications

Bachelor's or Master's degree in Computer Science, Engineering, Information Systems, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline.
8+ years of experience in Computer System Validation (CSV), Quality Assurance, or GxP-regulated environments.
3+ years of experience leading validation teams, validation programs, or quality compliance initiatives.
Experience supporting regulated systems throughout the software development lifecycle (SDLC).

Preferred Qualifications

Experience leading validation activities for global, enterprise-scale digital platforms.
Experience implementing Computer Software Assurance (CSA) and risk-based validation methodologies.
Experience validating cloud-based and SaaS platforms.
Experience supporting Agile and product-centric delivery organizations.
Experience driving validation automation and digital transformation initiatives in Life Sciences domain.

Required Skills

Computer System Validation (CSV) expertise.
Strong knowledge of GxP regulations, FDA 21 CFR Part 11, Annex 11, and Data Integrity requirements.
Validation lifecycle management including Validation Plans, Risk Assessments, RTM, IQ/OQ/PQ, and VSRs.
Requirements Traceability Matrix (RTM) creation, governance, and compliance management.
Risk-based validation and test strategy development.
Audit and inspection readiness management.
Quality Management Systems (QMS), CAPA, deviation, and change control processes.
Validation management tools such as ALM, Jira, Validation Management (VM), or equivalent platforms.

Good-to-Have Skills

Computer Software Assurance (CSA).
GAMP 5 methodology.
Validation of Salesforce, Mulesoft, cloud, and SaaS solutions.
Automated testing and validation frameworks.
DevOps, CI/CD, and release management practices.
Quality metrics, KPI reporting, and trend analysis.

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