Specialist - IT Quality

Job Description

In this vital role, you will lead the execution of complex or novel validation assignments requiring strategic planning and development of new or improved validation techniques, deviations, and procedures. You will supervise validation activities, conduct internal audits, perform risk assessments for requalification needs, and establish policies for computer system re-validation. This position requires active participation throughout all qualification/validation phases of computerized systems, providing technical guidance and making independent decisions to ensure compliance with regulatory and quality standards. Key Responsibilities Validation Review & Oversight: Review and approve validation/qualification packages for computerized systems ensuring completeness, accuracy, regulatory compliance (21 CFR Part 11, EU Annex 11, GAMP), and adherence to internal validation policies. Approve Requirement Specifications, Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Traceability Matrices. Review System Life Cycle documents and Data Integrity Assessments, confirming accuracy and regulatory compliance. Deviation and Change Control Management: Serve as Owner or QA contact for deviations, managing initiation, investigation, resolution, and closure. Initiate, review, approve, and track Change Control requests related to computerized systems (Trackwise/Veeva, ServiceNow). Manage CAPA and Effectiveness Verification activities as QA contact or owner. Periodic Review and Audit Trails: Review and approve periodic system reviews and audit trail reports to maintain system integrity and compliance. Supplier Management: Support supplier evaluations to ensure quality, compliance, and performance standards are met. Quality Assurance & Documentation: Approve operational and administrative SOPs and Work Instructions aligned with regulatory requirements. Apply analytical skills to evaluate complex quality issues using quantitative and qualitative data, including trend analysis, and develop effective solutions. Drive continuous improvement initiatives within validation and quality assurance processes. Regulatory Support: Participate in and support regulatory inspections and audits. Assist with Management Review Process and Integrated Systems Assessment (ISA) activities as needed. Training and Leadership: Provide training, guidance, and mentorship on validation and quality assurance practices. Lead projects or teams as required, demonstrating strong decision-making and leadership capabilities. Work Location: This role requires working from Amgen's Hyderabad office as per site policies. Basic Qualifications Master's degree with at least 7 years of experience in Software and Systems Quality Assurance, OR Bachelor's degree with at least 10 years of Software and Systems Quality Assurance experience. Preferred Qualifications Strong knowledge of 21 CFR Part 11, EU Annex 11, and GAMP standards. Proven experience in computerized system validation (CSV) and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP). Experience managing Change Control, Deviations, CAPAs, and effectiveness checks within quality systems. Strong analytical and problem-solving skills for resolving complex quality issues. Proven leadership skills with experience leading teams or projects. Ability to work independently with minimal supervision. Familiarity with tools such as HP ALM, Jira, Confluence, TrackWise, Documentation Management Systems, LIMS, SAP, and Maximo. Broad technical expertise and familiarity with industry standards. Soft Skills Excellent decision-making and problem-solving abilities. Effective communication and collaboration with senior leadership and external experts. Strong training and mentoring skills. High attention to detail and quality orientation.