Specialist IS Business Analyst

Amgen Inc. (IR); Telangana; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Amgen Inc. (IR) seeks a senior Validation lead to head the CSV team for GMP High Salesforce applications.

You will govern validation governance, risk-based decisions, and drive compliant delivery of validation plans, IQ/OQ/PQ, RTMs, and VSRs while collaborating with Product, Quality, and Regulatory teams. You will mentor Validation Engineers, maintain end-to-end traceability, support audits and CAPA, deviations, and change control, and push continuous improvement to shorten cycle times while

Qualifications

• Minimum 8+ years in CSV, QA, or GxP environments with leadership experience.
• Strong knowledge of validation lifecycle, RTM governance, and regulatory expectations.
• Experience delivering end-to-end validation for validated systems and platforms.

Responsibilities

• Lead validation strategy, governance, and execution for GxP applications and digital platforms.
• Own validation deliverables including IQ/OQ/PQ protocols, VSRs, and RTMs.
• Establish end-to-end traceability between requirements, risks, and validation evidence.
• Ensure inspection readiness, audits, CAPA, deviation management, and change control.

Skills

CSV expertise

GxP regulations

RTM creation

Validation lifecycle

Audit readiness

Change control

Quality metrics

Education

Bachelor's or Master's degree in Computer Science / Engineering / Life Sciences

Tools

ALM

Jira

Validation Management (VM)

Job description

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.

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen