Not specified; competitive total rewards plans ali...
Master's degree with 7 years experience
Bachelor's degree with 10 years experience
Risk-based validation (rbv) methodologies
This role leads the execution of complex assignments requiring strategic planning and development of new validation techniques for computerized systems
Job Summary
This role leads 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 deviations, ensuring proper investigation and resolution in alignment with regulatory standards.
Amgen offers a collaborative culture where employees help transform patient lives while pursuing professional growth through competitive benefits.
Matching Summary
This role leads 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 comprehensive benefits
Skills & Requirements
Must-have
Master's degree with 7 years experience
Bachelor's degree with 10 years experience
Risk-based validation (RBV) methodologies
Computer Software Assurance (CSA) principles
21 CFR Part 11 and EU Annex 11 regulations
GAMP standards application
GxP system validation expertise
Nice-to-have
Data analysis and visualization skills
Power BI or Smartsheet proficiency
Cross-functional team leadership
Continuous improvement initiatives
Training strategy contribution
Key Requirements
Master's degree + 7 years experience OR Bachelor's + 10 years
Experience with Trackwise, Veeva, ServiceNow, HP ALM, Jira
Knowledge of GMP, GLP, GCP, GDP regulations
Ability to work from Hyderabad office as per policy