Specialist - IT Quality

Responsibilities

• Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Serve as Owner or QA Contact for handling the Deviations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to management's attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN).
• The candidate will be required to go into the office as dictated by the site policy.
• Validation
• Validation DocumentationReview and approve all validation documentation, ensuring compliance with regulatory requirements and internal quality standards.
• Requirement Specifications & Test ProtocolsReview and approve Requirement Specifications, Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices.
• System Life Cycle DocumentsReview and approve System Life Cycle Documents (e.g., test protocols) prior to their use in production.
• Data Integrity AssessmentsReview and approve Data Integrity Assessments to ensure data is accurate and complies with regulatory standards.
• Change Control Management Initiate, review, and approve Change Control requests, acting as the QA contact for changes in systems (e.g Trackwise/Veeva , ServiceNow)

Periodic Review/Audit Trail

• System Periodic Reviews & Audit TrailsReview and approve periodic system reviews and audit trail reports to ensure system integrity and compliance.

Supplier Management

• Supplier Evaluations

• :

  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.