About the Position

IT Quality-Specialist

India - Hyderabad

JOB ID: R-238800

LOCATION: India - Hyderabad

WORK LOCATION TYPE: On Site

DATE POSTED: Oct. 16, 2026

CATEGORY: Quality

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation.

This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities.

Responsibilities

Validation
- Demonstrated expertise in risk-based validation (RBV) methodologies, providing execution and guidance to cross-functional teams on complex GxP projects while ensuring alignment with Computer Software Assurance (CSA) principles.
- Proven ability to serve as the QA point of contact for assigned GxP systems, ensuring timely review and approval of documentation in compliance with Amgen’s standard operating procedures and applicable regulatory standards.
- Change Control Management: Drive Change Request (CR) and Change Control processes, from initiation through approval, ensuring accurate system impact assessment and documentation.
- Validation Documentation: Review and approve all validation documentation, ensuring compliance with regulatory requirements and internal quality standards.
- Requirement Specifications & Test Protocols: Review and approve Requirement Specifications, Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices.
- System Life Cycle Documents: Review and approve System Life Cycle Documents (e.g., test protocols) prior to their use in production.
- Data Integrity Assessments: Review and approve Data Integrity Assessments to ensure data is accurate and complies with regulatory standards.
Periodic Review/Audit Trail
- Review and approve periodic system reviews and audit trail reports to ensure system integrity and compliance.
Supplier Management
- Provide support for supplier evaluations as needed, ensuring suppliers meet quality, compliance, and performance standards.
Deviation & CAPA Management
- Initiate and manage deviations (major and minor) as required. Serve as the primary QA contact for deviations, ensuring proper investigation and resolution.
- Act as the quality reviewer and approve for problem records in ServiceNow, ensuring that all records meet internal quality standards.
- CAPA & Effectiveness Verification (EV): Serve as the QA contact or owner for Corrective and Preventive Actions (CAPA) and Effectiveness Verification (EV) records, ensuring timely and effective resolution.

What we expect from you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

Master’s degree with a minimum of 7 years experience in Software and Systems Quality assurance OR
Bachelor’s degree with a minimum of 10 years of Software and Systems Quality assurance experience

Preferred Qualifications:

Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards.
Proven experience in the validation of computerized systems (GxP).
Strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP).
Experience managing quality assurance processes, including Major and Minor Deviations.
Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills.
Strong decision-making abilities with the capacity to drive tasks to completion.
Ability to work independently with minimal supervision.
Leadership skills with experience leading projects, teams, or tasks.
Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise, Documentation Management Systems, LIMS, SAP, and Maximo.
Broad technical expertise within specialty area and familiarity with industry standards.
Ability to provide training, guidance, and contribute to team quality.
Works closely with senior staff and external experts to extend capabilities and enhance performance.

Data analysis skills (Good to have):

Perform data analysis to create impactful visuals and dashboards for informed decision-making.
Design clear, engaging charts and graphics for presentations and reports.
Utilize tools like Power BI, Smartsheet, or similar to develop interactive, data-driven visuals.
Translate complex data into concise, compelling visual stories for diverse audiences.
Collaborate with cross-functional teams to align visual outputs with business goals.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed, and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Attention Job Applicants

At Amgen, we are relentless in applying the highest ethical standards to our products, services, and communications. Consistent with this, we expect all job applicants to act with honesty and integrity. Providing any false or misleading information, or omitting material information during the hiring process, may result in immediate disqualification from the hiring process or termination if already employed. We appreciate your cooperation in helping us uphold these standards.

IT Quality-Specialist

Job description