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Amgen Technology Private Limited

MDM Validation Associate Analyst

3-8 Years

This job is no longer accepting applications

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  • Posted 2 months ago
  • Over 50 applicants

Job Description

  • Plan, coordinate, and execute validation activities for data products and software applications in a GxP-regulated environment.
  • Develop and maintain validation documentation, including Validation Plans, IQ/OQ protocols, and Validation Reports, ensuring review and approval.
  • Ensure validation strategies comply with regulatory requirements, company standards, and evolving SOPs.
  • Write and review Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents.
  • Collaborate with cross-functional teamsquality assurance, system owners, RunOps, engineeringto drive validation efforts and meet project timelines.
  • Track validation progress and align activities with product owner and scrum master to stay on schedule.
  • Document validation activities thoroughly, managing deviations, change controls, and non-conformance.
  • Identify and implement process improvements to enhance validation efficiency and quality.
  • Stay current on new technologies, validation trends, and industry best practices.
  • Utilize tools like ALM and JIRA for validation script development, execution, and project tracking in Agile/SAFe environments.
  • Apply strong problem-solving, analytical, and communication skills to resolve data-related issues and collaborate effectively with global teams.
  • Preferred knowledge includes compliance (GDPR, HIPAA), MDM domain experience, and relevant certifications (CSV, Agile, SAFe).

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Indian

About Company

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average, and we are also part of the Nasdaq-100 Index, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

Job ID: 116889979