Associate System Analyst Job in Hyderabad at Amgen

Amgen is hiring for the role of Associate System Analyst!

Responsibilities of the Candidate:

• Develop comprehensive test plans and strategies based on project specifications and requirements.
• Perform manual and automated testing of software applications, including functional, regression, and performance testing.
• Document and report defects identified during testing and collaborate with development teams for resolution.
• Maintain detailed records of test plans, test cases, and test results to ensure traceability and compliance.
• Validate test scenarios against feature acceptance criteria and customer expectations.
• Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability.
• Find opportunities to enhance testing efficiency and minimize manual efforts.
• Evaluate and adopt tools and technologies to improve automation capabilities.
• Keep validation documentation updated and aligned with GxP standards.
• Ensure strict consistency to change management processes for validated systems.
• Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GxP, DevOps and Test Automation.
• Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, fix, and improving new and existing applications and platforms.
• Collaborate with business and data collaborators to gather requirements, assess data needs, and ensure data quality, privacy, and compliance across ETL pipelines.
• Maintain detailed documentation of software designs, code, and development processes.
• Work on integrating with other systems and platforms to ensure seamless data flow and functionality.
• Stay up to date on Veeva Vault Features, new releases and standard processes around Veeva Platform Governance.

Requirements:

• Bachelor’s degree and 2 to 6 years of Information Systems experience or related field.
• Experienced in GxP validation process in Pharmaceutical Industry
• Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology
• Experience with HP ALM/Veeva Validation Manager (VVM)
• Experience with Agile software development methodologies (Scrum)
• Superb communication skills and the ability to work with senior leadership with confidence and clarity
• Experience in writing requirements for the development of a modern web application
• Solid understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11
• Proficiency in automation tools, data systems, and validation software