IT Quality Specialist
Amgen · Hyderabad, India
QualityFull-timeCompany career page
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Role summary
Amgen seeks an IT Quality Specialist to oversee validation and qualification of computerized systems in a regulated pharmaceutical environment. The role involves managing complex validation activities, deviation investigations, change controls, and ensuring compliance with regulatory and quality standards across GxP systems.
What they're looking for
- Expertise in risk-based validation (RBV) methodologies and Computer Software Assurance (CSA) principles
- Demonstrated experience managing change control and deviation processes in regulated environments
- Knowledge of validation documentation requirements and regulatory compliance standards
- Proficiency with change management tools such as Trackwise, Veeva, or ServiceNow
- Strong analytical and problem-solving skills with ability to evaluate complex quality issues
- Experience serving as QA point of contact for GxP computerized systems
What you'll be doing
- Review and approve validation documentation, including requirement specifications, test protocols, and traceability matrices
- Lead risk assessments and conduct internal audits to identify requalification needs and establish re-validation policies
- Initiate and manage deviations and corrective/preventive actions as primary QA contact
- Drive change control processes from initiation through approval with accurate impact assessment
- Support regulatory inspections and participate in management review and continuous improvement initiatives
Privacy & handoff
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