It Quality-specialist

Amgen UK

Hyderabad, India
Validation techniques
Deviations and procedures
Risk assessments
In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures

Job Summary

  • In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures.
  • 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.
  • In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Matching Summary

In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures.

Skills & Requirements

Must-have

  • validation techniques
  • deviations and procedures
  • risk assessments
  • computerized systems validation
  • GxP regulations
  • data integrity

Nice-to-have

  • award-winning culture
  • collaborative and science based
  • continuous improvement efforts
  • training initiatives and strategy

Key Requirements

  • Master’s degree with 7 years experience
  • Bachelor’s degree with 10 years experience
  • 21 CFR Part 11, EU Annex 11, GAMP standards
  • GxP regulations (GMP, GLP, GCP, GPvP, GDP)
  • Experience with Track Wise, Veeva, ServiceNow

Work Rights

Not specified

Tailored Resume

Cover Letter