Specialist IS Business Analyst

Amgen SA; Hyderabad; Presencial; INR 1 800 000 - 3 200 000; Tempo integral

Resumo da oferta

Amgen SA in Hyderabad, India is seeking a senior Lead for Computer System Validation (CSV) to oversee validation governance and ensure GxP compliance across digital platforms. You will drive risk-based decision making, maintain RTM traceability, and lead a high-performing validation team.

You will partner with Product, Quality, Regulatory and Technology teams to enable compliant, timely delivery of business initiatives and support regulatory inspections with a proactive quality mindset.

Qualificações

• Bachelor's or Master's degree in a relevant field.
• 8+ years in CSV, QA, or GxP environments.
• 3+ years leading validation teams or programs.
• Experience supporting regulated systems across the SDLC.

Responsabilidades

• Lead validation strategy, governance and execution for GxP systems and digital platforms.
• Own validation activities ensuring compliance with SOPs, regulatory requirements, and industry standards.
• Author and own Validation Plans, Risk Assessments, IQ/OQ/PQ, VSRs, and RTMs.
• Maintain end-to-end RTM traceability linking requirements, risks, tests, defects and compliance.
• Support inspections, CAPA, deviation management and change control.
• Own validation strategy, testing scope and end-to-end system validation.
• Mentor Validation Engineers and drive a quality-first culture.
• Collaborate with Product, Quality, Regulatory and Tech teams to ensure timely delivery.

Conhecimentos

CSV expertise

GxP regulations

RTM governance

Risk-based validation

Audit readiness

Team leadership

SDLC support

Quality mindset

Formação académica

Bachelor's/Master's in CS/Engineering/ Life Sciences

Ferramentas

ALM

Jira

Validation Management (VM)

Descrição da oferta de emprego

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.