16 Aug
|
AMGEN
|
Hyderabad
CAREER CATEGORY
Information Systems
JOB DESCRIPTION
Description
Amgen harnesses the best of biology and technology to fight the world’s toughest
diseases and make people’s lives easier, fuller, and longer. We discover,
develop, manufacture, and deliver creative medicines to help millions of
patients. Amgen helped establish the biotechnology industry more than 40 years
ago and remains on the cutting edge of innovation, using technology and human
genetic data to push beyond what is known today.
About the Role
The Technology Compliance Specialist is part of the Amgen Breda site Technology
team and supports Technology compliance, validation, periodic review, and data
integrity activities for GxP computerized systems at the ABR site.
The role provides additional technology compliance support required by
volume-driven growth, new technology deployments through DMI and site
modernization programs, and the expansion of continuous improvement solutions,
including the additional effort needed to administer, track, and maintain
compliance-related ServiceNow records and workflows.
This role is focused on technology compliance operations and administrative
oversight activities that can be performed remotely in partnership with
manufacturing, quality, validation, system owners, Site Technology Compliance
Leads and global technology teams. The role provides centralized support,
coordination, documentation, tracking, analysis, and governance support to help
maintain systems in a validated state of operation.
The individual will support the planning, monitoring, documentation, and
reporting of compliance and validation lifecycle activities, including periodic
reviews, data integrity assessments, inspection-readiness documentation,
deviation support, and compliance metrics. The role will collaborate with Site
Technology Compliance Leads, validation stakeholders, quality, system owners,
and technology teams to promote consistent processes, quality deliverables, and
alignmen
📌 Technology Compliance Specialist (Hyderabad)
🏢 AMGEN
📍 Hyderabad