Validation Engineer - Hyderabad / Secunderabad, Telangana - Amgen Technology Private Limited

Roles & Responsibilities: · 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 ...

Role Responsibilities: · Define and execute validation plans and risk assessments · Create and review user and functional requirement documents · Maintain compliance with 21 CFR Part 11 and Annex 11 · Manage system validation lifecycle including change control · Key Deliverables: ...

Roles & Responsibilities: · 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 ...

Key Deliverables: · Develop and maintain validation plans and documentation · Execute validation protocols aligned with regulatory guidelines (21 CFR Part 11, Annex 11) · Support system lifecycle validation including periodic reviews and change management · Provide technical supp ...

Key Deliverables: · Create and execute IQ, OQ protocols ensuring GxP compliance · Conduct manual and automated testing for functional and performance assurance · Maintain validation documentation aligned with regulatory standards · Collaborate on continuous improvement and automa ...

In this vital role you will be working closely with Business collaborators, Product Owner, Business Analysts, Developers, and Testers to ensure that Validation strategy and work are produced for IT Systems. This role will be pivotal in ensuring compliance, efficiency, and innovat ...

Role Description: · We are seeking a highly skilled Validation Engineer to join our team. You will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical syst ...

Let's do this. Let's change the world. · We are seeking an experienced Validation Engineer to work on a GxP platform supporting the Regulatory Submission system and Clinical Trial Registry system. This role will be pivotal in ensuring compliance, efficiency, and innovation in the ...

In this vital role, you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs, and ensuring the availability and performance of critical systems and applications. This position involves working closely with pro ...

In this vital role, you will support the implementation and operational management of real-world evidence platforms at Amgen, ensuring integrity and compliance of critical systems and data. The role requires close collaboration with developers, business analysts, and product mana ...

Key Deliverables: · Develop and execute validation plans and protocols for GxP-regulated systems · Ensure system documentation complies with 21 CFR Part 11, Annex 11, and CSA guidance · Support change control, incident handling, and periodic review for validated systems · Collabo ...

Key Deliverables: · Define and execute validation strategies for GxP-regulated IT systems · Create and manage validation documentation using Veeva VM Testing Vault · Execute test cases, track defects, and ensure compliance with regulatory standards · Generate reports and dashboar ...

Key Deliverables: · Execute validation protocols (IQ, OQ, PQ) for RWE platforms under GxP guidelines · Create and maintain comprehensive test plans, test cases, and documentation · Perform manual and automated testing across functional, regression, and performance layers · Ensure ...

Roles & Responsibilities: · 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 ...

Roles & Responsibilities: · Develop detailed test plans and strategies based on project requirements and specifications · Perform manual and automated testing of software applications, including functional, regression, and performance testing · Document and report defects and iss ...

Roles & Responsibilities: · Monitor, test, and resolve issues related to case intake and case processing across multiple systems. · Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues · Owne ...

Roles & Responsibilities: · Translate Amgen requirements into the language of the CMO · Identify and assess validation/quality risks to enable risk-based decisions · Validation document author/approver · Determine appropriate sample plans and acceptance criteria for primary and s ...

Key Deliverables: · Develop and execute validation protocols (IQ/OQ) for GxP-compliant systems · Design automated test suites for APIs, data pipelines, and custom software · Collaborate with cross-functional teams to ensure validation and documentation compliance · Maintain valid ...

Roles & Responsibilities: · Advising clients on how to meet compliance requirements using a risk-based approach. · Develop validation documentation and standard operating procedures for various GxP applications. · Develop test protocols that thoroughly test business requirements. ...

Key Deliverables: · Develop and maintain validation plans and lifecycle documentation · Execute risk-based validation for regulated systems and applications · Support change control and continuous validation activities · Ensure compliance with GxP, 21 CFR Part 11, and Annex 11 re ...