It Quality Specialist

Amgen Inc

Hyderabad, India
Not specified; competitive total rewards plans ali...
10-14 years software quality assurance experience
Validation of gxp computerized systems
Risk-based validation (rbv) methodologies
This role involves leading the execution of complex assignments requiring strategic planning and development of new validation techniques for computerized systems

Job Summary

  • This role involves leading the execution of complex assignments requiring strategic planning and development of new validation techniques for computerized systems.
  • The position requires serving as the primary QA contact for major and minor deviations, ensuring timely resolution and compliance with regulatory standards.
  • Amgen offers a collaborative culture where employees help transform patient lives while pursuing professional growth through competitive benefits and comprehensive Total Rewards Plans.

Matching Summary

This role involves leading the execution of complex assignments requiring strategic planning and development of new validation techniques for computerized systems.

Salary

Not specified; Competitive total rewards plans aligned with local industry standards; Base salary plus benefits included

Skills & Requirements

Must-have

  • 10-14 years software quality assurance experience
  • Validation of GxP computerized systems
  • Risk-based validation (RBV) methodologies
  • Computer Software Assurance (CSA) principles
  • 21 CFR Part 11 and EU Annex 11 regulations
  • GAMP standards application
  • Deviation and CAPA management

Nice-to-have

  • Data analysis with Power BI or Smartsheet
  • Experience with Trackwise, Veeva, ServiceNow
  • Leadership in cross-functional teams
  • Supplier evaluation support
  • Training strategy contribution
  • Integrated Systems Assessment (ISA) participation

Key Requirements

  • Master's or Bachelor's degree
  • Minimum 10-14 years experience
  • Proven GxP system validation expertise
  • Strong decision-making abilities

Work Rights

Not specified

Tailored Resume

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