SAP Validation Functional Analyst - Hyderabad / Secunderabad, Telangana - Amgen Technology Private Limited

    Amgen Technology Private Limited
    Amgen Technology Private Limited Hyderabad / Secunderabad, Telangana

    2 days ago

    Full time
    Description

    Roles & Responsibilities:

    • Lead all aspects of the qualification and validation deliverables of SAP ERP systems to ensure they meet industry standards and regulatory requirements.
    • Create and implement detailed validation plans for SAP implementations, aligning with project timelines and deliverables.
    • Collaborate with ERP projects and product teams, Quality Assurance, and business collaborators to define validation requirements, ensuring comprehensive testing and compliance.
    • Develop and maintain critical validation documentation, including IQ, OQ, test scripts, and traceability matrices.
    • Know the latest with GxP regulations, ensuring ongoing compliance and readiness for audits.

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients.

    Basic Qualifications and Experience:

    • Master s degree and 1 to 3 years of Computer Science, IT or related field experience OR
    • Bachelor s degree and 3 to 5 years of Computer Science, IT or related field experience OR
    • Diploma and 7 to 9 years of Computer Science, IT or related field experience
    • Extensive SAP Validation Experience: Minimum of 2 years in validating SAP systems in a regulated environment.
    • Documentation Proficiency: Expertise in creating and managing validation documentation, including IQ, OQ, and test scripts.
    • Regulatory Compliance Knowledge: In-depth understanding of GxP regulations
    • Roles & Responsibilities:Lead all aspects of the qualification and validation deliverables of SAP ERP systems to ensure they meet industry standards and regulatory requirements.
    • Create and implement detailed validation plans for SAP implementations, aligning with project timelines and deliverables.
    • Collaborate with ERP projects and product teams, Quality Assurance, and business collaborators to define validation requirements, ensuring comprehensive testing and compliance.
    • Develop and maintain critical validation documentation, including IQ, OQ, test scripts, and traceability matrices.
    • Know the latest with GxP regulations, ensuring ongoing compliance and readiness for audits.

    What we expect of youWe are all different, yet we all use our unique contributions to serve patients.

    Basic Qualifications:

    • Master s degree and 1 to 3 years of Computer Science, IT or related field experience OR
    • Bachelor s degree and 3 to 5 years of Computer Science, IT or related field experience
    • Diploma and 7 to 9 years of Computer Science, IT or related field experience
    • Preferred Qualifications:Experience with Agile / Scaled Agile Framework (SAFe) methodologies for software delivery.
    • Experience with validations tools such as CDOCs, ALM and JIRA.
    • Professional CertificationsScrum 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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