IT Quality-Specialist

Overview

Lead complex IT quality and computer system validation work for GxP systems at Amgen, serving as QA point of contact, reviewing validation packages and deviations, and driving change control.

What you'll do

• Lead the execution of complex or novel assignments requiring strategic planning and development of new or improved validation techniques, deviations, and procedures.
• Supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation.
• Actively participate in all phases of qualification and validation of computerized systems, including evaluating projects, providing guidance, and determining requirements for each system or equipment.
• Review validation and qualification packages for completeness, accuracy, sound rationale, regulatory compliance, and accurate data analysis.
• Serve as Owner or QA Contact for Minor and Major Deviations, comparing results against acceptance criteria and working with departments to resolve exceptions.
• Bring critical exceptions or deviations to management's attention and initiate and enforce necessary improvements and corrections to systems and processes.
• Initiate, implement, and track completion of Change Control and deviation requests related to computer systems.
• Drive Change Request and Change Control processes from initiation through approval, ensuring accurate system impact assessment and documentation (e.g., Trackwise/Veeva, ServiceNow).
• Review and approve all validation documentation, including Requirement and Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices.
• Review and approve System Life Cycle Documents prior to their use in production, and review and approve Data Integrity Assessments.
• Review and approve periodic system reviews and audit trail reports to ensure system integrity and compliance.
• Provide support for supplier evaluations as needed.
• Initiate and manage deviations and serve as primary QA contact, including acting as quality reviewer and approver for problem records in ServiceNow.
• Serve as QA contact or owner for CAPA and Effectiveness Verification records.
• Act as Business Owner for specific GxP Computerized Systems programs and projects, ensuring regulatory compliance and alignment with business objectives.
• Review and approve operational and administrative SOPs and Work Instructions.
• Apply analytical skills, including trend analysis, to evaluate complex problems and contribute to continuous improvement.
• Assist with training initiatives and strategy, support the Management Review Process and Integrated Systems Assessment process, and participate in regulatory inspections as required.

What you'll need

• Master's degree with a minimum of 7 years of experience in Software and Systems Quality assurance, OR Bachelor's degree with a minimum of 10 years of Software and Systems Quality assurance experience.
• Demonstrated expertise in risk-based validation (RBV) methodologies and alignment with Computer Software Assurance (CSA) principles.

Nice to have

• Strong understanding of 21 CFR Part 11, EU Annex 11, and 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, and use tools like Power BI, Smartsheet, or similar.

Details

• Location: Amgen office in Hyderabad, India (Amgen India-AIN).
• Office attendance required as dictated by site policy.