PHARMAFull-time
IT Quality-Specialist
HYDERABAD (IN)ONSITEPOSTED: 8/14/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE DEFINITION & RESPONSIBILITIES
Lead execution and strategic planning of qualification/validation for complex GxP computerized systems and equipment.
Review and approve validation packages, requirement specifications, test protocols, summary reports, and System Life Cycle documents.
Drive Change Control, deviation management (major/minor), CAPAs, and Effectiveness Verification (EV) using platforms like TrackWise/Veeva and ServiceNow.
Perform Data Integrity Assessments, periodic system reviews, and audit trail reviews to maintain compliance with 21 CFR Part 11, EU Annex 11, and GAMP.
Provide QA oversight for risk-based validation (RBV), Computer Software Assurance (CSA), supplier evaluations, and support regulatory inspections.
REQUIRED VERIFIED SKILLS
Computer System Validation (CSV)
GxP
21 CFR Part 11
EU Annex 11
GAMP
Deviations
CAPA
Change Control
Risk-Based Validation
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Amgen is a leading global biopharmaceutical company committed to unlocking the potential of biology for patients suffering from serious illnesses. It discovers, develops, manufactures, and delivers innovative human therapeutics, focusing on areas with high unmet medical needs such as oncology, cardiovascular disease, bone disease, and inflammatory diseases.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.