Network and Infrastructure Qualification Lead

• Works with the project team to author qualification deliverables such as Infrastructure/Network specifications, Qualification Protocols, Test Cases, Risk Assessments, and Summary Reports
• Develop system development life cycle documents related to network infrastructure for a GMP lab.
• This includes system specification documents, qualification plans and test protocols, and procedures.
• Review qualification of infrastructure related to network and cloud-based services especially AWS
• Work with regional project teams to ensure global ITQA qualification strategy is understood and followed
• Maintain up-to-date knowledge and understanding of quality system requirements as they apply to infrastructure in accordance with GxP regulations, GAMP, industry standards, policies, and procedures

Requirements:

• Minimum of 4+ years of experience with infrastructure qualification in the pharmaceutical or biotech industry
• Thorough understanding of GMP regulations as it pertains to networks, data storage, disaster and recovery, data integrity, security etc.
• Experience with implementing AWS services in a GxP environment for short-term and long-term data storage.
• Experience in the creation and execution of infrastructure qualification strategies
• Hands on experience with on-prem server, IaaS and PaaS environments in a GxP environment.
• Willing to travel to client site if and when needed.
• Bachelor's degree in information systems, engineering, computer science or other related IT field
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above