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Amgen Inc
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SAP Validation Functional Analyst

SAP Validation Functional Analyst

Amgen Inc

5 - 9 years

1 - 5 Lacs

hyderabad

Posted:1 week ago| Platform:

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Skills Required

gxp sap documentation sap module regulations pq ecc data validation csv sap erp test scripts gamp sap s hana qms grc computer system validation jira capa erp oq alm software testing iq veeva servicenow quality assurance agile

Work Mode

Work from Office

Job Type

Full Time

Job Description

What you will do

In this vital role, you will support the qualification, validation, and compliance processes for SAP ERP solutions and related platforms. You will work closely with senior team members, Quality, and business partners to ensure validation deliverables are executed to meet industry standards and regulatory requirements in a Life Sciences environment.

Roles & Responsibilities:

Execute validation deliverables for SAP ERP systems (ECC, S/4HANA, BTP, GRC, and related platforms) in alignment with Amgens procedures and regulatory expectations.
Support the creation, execution, and review of validation documentation (e.g., Validation Plan, Requirements, IQ, OQ, PQ/UAT test scripts, Traceability Matrix, Validation Report).
Collaborate with project teams, quality assurance, and business stakeholders to ensure requirements are clearly defined and properly tested.
Assist in maintaining operational compliance for SAP systems, including activities related to Incident Management, Problem Management, Change Control, CAPA, and Deviation tracking.
Participate in periodic reviews, user access reviews (UARs), and audit trail checks to maintain ongoing compliance.
Contribute to audit readiness by supporting evidence collection and responding to inspection requests.
Stay current with evolving GxP regulations, guidelines (21 CFR Part 11, Annex 11, GAMP 5), and Amgens IT-QMS.
Explore opportunities to leverage digital validation and automation tools to improve efficiency.

Basic Qualifications and Experience:

Any degree and 5-9 years of Computer Science, IT or related field experience OR
Extensive SAP Validation Experience: Minimum of 2 years in validating SAP systems in a regulated environment.
Documentation Proficiency: Expertise in creating and managing Risk based validation documentation including Validation Plan, Specifications, IQ, OQ, PQ/UAT, RTM and Validation Report.
Regulatory Compliance Knowledge: In-depth understanding of GxP regulations.

Preferred Qualifications:

Experience with validation or ITSM tools (e.g., ServiceNow, Veeva CDOCs, ALM, JIRA)
Exposure to Agile or SAFe methodologies for IT delivery
Good to have SAP or quality-related certifications

Professional Certifications

Scrum Master (preferred)
SAP certification (preferred)

Soft Skills:

Strong capability to analyze complex issues and develop effective solutions.
Excellent verbal and written communication skills for collaborator interactions and documentation.
High degree of precision in managing validation documentation and ensuring regulatory compliance.
Ability to manage changing requirements and priorities effectively.
Ability to focus on team collaboration and achieving project goals.

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SAP Validation Functional Analyst