20 Aug
|
AMGEN
|
Hyderabad
What you will do
Lets do this. Lets change the world.
In this critical role, you will serve as the end-to-end Change Owner for SAP / ERP portfolio , ensuring that all system changes are planned, assessed, implemented, validated , and released in compliance with GxP regulations, Amgen IT-QMS and change management process aligned to global best practices .
You will partner closely with Business, ERP product delivery teams, Validation, and Quality to enable risk-based, audit-ready, and productive change execution across Amgens SAP landscape.
Roles Responsibilities:
Act as the single point of accountability for SAP ERP changes across projects, enhancements, fixes, and operational maintenance.
Own and execute the change lifecycle including:
Change initiation and classification
Impact and risk assessment
Approval coordination ( Change managers, Business, SMEs, Quality, CAB)
Implementation oversight
Post-implementation verification and closure
Ensure all SAP changes comply with :
21 CFR Part 11 / EU Annex 11 regulations
ALCOA+ data integrity principles
GAMP 5 and CSA (Computer Software Assurance)
Partner with Quality and Compliance to:
Assess validation impact of changes
Assess required validation deliverables
Ensure traceability between requirements, risks, testing, and release
Support SAP platforms including ECC, S/4HANA, BTP, GRC, Solution Manager ( Solman) , integrations, and boundary systems.
Ensure changes maintain effective controls for:
User access and segregation of duties
Audit trails and logging
Configuration vs. customization decisions
Coordinate with SAP development, functional , testers and SMEs to ensure timely and compliant deployment of changes.
Support release planning, cutover activities, and hypercare as required .
Maintain audit-ready documentation and evidence for change, validation, incident, and deviation activities.
Proactively identify prospects to simplify and optimize change processes, reduc
📌 Erp Change Owner Hyderabad
🏢 AMGEN
📍 Hyderabad