Job Summary
The Sr QA Validation Specialist (IT Infrastructure) is responsible for implementing policies and procedures to qualify IT infrastructure platforms and validate computer systems.
Key Responsibilities:
* Analysing the results of testing and determines the acceptability of results against predetermined criteria
* Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements
* Identifying current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation vital to ensure compliance within the operation
* Leading process improvement projects to improve the qualification of infrastructure platforms
* Coordinating with other departments or outside contractors/vendors to complete validation tasks
* Participating in regulatory audits and communicates company's computer validation policies
* Assessing company's infrastructure platforms and identifies any potential security gaps and ensure the best data integrity practices are implemented
* Training Specialists and Technicians
* Technical writing experience Generating, reviewing, and approving of qualification/validation documents
* Completing risk assessments in relation to IT infrastructure activities
* Advising and supporting all teams on IT infrastructure and computer systems qualification activities
Requirements:
* Bachelor's degree in Computer Science, Information Systems, or a related field
* At least 5+ years of experience in IT CSV engineering or a related field
* Experience with principles of infrastructure and VMware in the Private & Hybrid Cloud domain
* Understanding of network infrastructure devices, firewalls and active directory administration
* Solid understanding and experience with Computer Systems Validation and/or IT Auditing
* Thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7 A, FDA parts 210 and 211