What you will do

In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of current 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

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 Minor and Major Deviations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to managements 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.

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 Amgens standard

📌 IT Quality-Specialist (Hyderabad)
🏢 Amgen
📍 Hyderabad