Specialist IS Business Analyst
Amgen · Hyderabad
Career Category
Information SystemsJob 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.
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.