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Specialist IS Bus Sys Analyst

Specialist IS Bus Sys Analyst

ConfidentialHyderabad / Secunderabad, Telangana
25 days ago
Job description

ollaborate with System Architects and Product owners to manage Validation Strategy and Deliverables for Amgen's R&D Veeva Vault Platform and its Hosted Applications.

  • Develop and manage test cases, protocols, and validation documentations within the Veeva Validation Manager Vault.
  • Provide experienced technical support in validation to meet objectives of quality, output, and cost in developing, troubleshooting, standardizing, and improving new and existing validation methods / procedures.
  • Prepare, implement, document, and report validation protocols in line with GxP and other regulatory requirements and standards.
  • Ensure that all validation test procedures are in line with current technology, corporate, and governmental regulations.
  • Perform IQ, OQ, and PQ validation on processes, equipment, and systems in conjunction with suppliers as appropriate.
  • Implement test scripts to ensure system compliance with regulatory requirements and organizational standards.
  • Identify, document, and track defects during the testing process.
  • Collaborate with development teams to resolve defects and validate fixes.
  • Ensure all testing and validation activities align with GxP, FDA 21 CFR Part 11, and other regulatory standards.
  • Maintain comprehensive audit trails and validation documentations to support regulatory inspections.
  • Configure and optimize workflows within the Validation Manager Testing Vault to streamline test management and approval processes.
  • Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements.
  • Act as a liaison between technical teams and customers to ensure system requirements are met.
  • Provide training to end-users on Veeva VM Testing Vault functionalities and standard processes.
  • Offer ongoing support to ensure effective use of the platform.
  • Generate reports and dashboards to monitor testing progress, defect trends, and validation status.

What we expect of you

Basic Qualifications :

  • Master's degree with 4 - 6 years of experience in Computer Science, Business, Engineering, IT, or a related field OR
  • Bachelor's degree with 6 - 8 years of experience in Computer Science, Business, Engineering, IT, or a related field OR
  • Diploma with 10 - 12 years of experience in Computer Science, Business, Engineering, IT, or a related field.
  • Solid understanding of the Veeva Clinical Platform and business processes.
  • 6-8 years of Global Pharmaceutical industry experience.
  • Solid understanding of pharmaceutical clinical operation and data management business processes.
  • Experienced in pharmaceutical regulations and specifications.
  • Solid understanding of GxP regulations, specifically 21 CFR Part 11.
  • Expertise in defining and implementing validation strategies aligned with regulatory requirements.
  • Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)).
  • Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity.
  • Familiarity with GxP Validation management tools such as ALM, Veeva Validation Manager, Vault, etc.

    • Preferred Qualifications :

  • Proficiency in automation tools and validation software.
  • Experience with DevOps, Continuous Integration, and Continuous Delivery methodologies.
  • Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies (Scrum Agile, etc.).

    • Professional Certifications :

  • Veeva Vault Platform Administrator (mandatory).
  • SAFe – DevOps Practitioner (preferred).
  • SAFe for teams (preferred).

    • Soft Skills :

  • Able to work under minimal supervision.
  • Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work.
  • Excellent analytical and gap / fit assessment skills.
  • Strong verbal and written communication skills.
  • Ability to work effectively with global, virtual teams.
  • High degree of initiative and self-motivation.
  • Ability to manage multiple priorities successfully.
  • Team-oriented, with a focus on achieving team goals.
  • Strong presentation and public speaking skills.

    • Skills Required

    Gxp, Alm, Continuous Integration, Data Management, Presentation Skills, Veeva, Data Validation

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