Job Description:
The individual in this position implements policies and procedures to qualify IT infrastructure platforms and validate computer systems. This includes planning, coordinating, and participating in a compliant qualification process for qualifying information technology infrastructure platforms.
Responsibilities:
* Analysing the results of testing and determining the acceptability of results against predetermined criteria.
* Investigating and troubleshooting problems which occur and determining solutions or recommendations for changes and/or improvements.
* Identifying current and anticipated requirements for compliant computerized operations and suggesting 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 communicating company's computer validation policies.
* Assessing company's infrastructure platforms and identifying any potential security gaps and ensuring the best data integrity practices are implemented.
* Training Specialists and Technicians.
* 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:
* Experience with principles of infrastructure and VMware in the Private & Hybrid Cloud domain, as well as an understanding of network infrastructure devices, firewalls and active directory administration.
* Solid understanding and experience with Computer Systems Validation and/or IT Auditing.
* Understanding of the interdependencies of change management, deviation and continuous improvement.
* Ability to work in a dynamic organization where innovative solutions are required to ensure a high-level of quality is achieved within required timelines.
* Thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211.
Education:
* Bachelor's degree in Computer Science, Information Systems, or a related field.
Experience:
* At least 5+ years of experience in IT CSV engineering or a related field.