RCM Technologies is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.
Our client is a major Pharmaceutical company looking to bring aboard talent.
This position for an IT Infrastructure Qualification Lead, ITIQ is responsible for the day-to-day authorizing and reviewing execution of IT Infrastructure Qualification (ITIQ) activities. Work with the broader QA Validation and IT Teams to ensure IT infrastructure qualification deliverables are completed per schedule
The IT Infrastructure Qualification Lead, (ITIQ) will:
- Act as the IT Infrastructure Qualification (ITIQ) Lead on the company ITIQ projects, take ownership of related tasks, work under minimal supervision, utilize industry experience and best judgement to make tactical decisions.
- Author the typical IT infrastructure qualifications deliverables such as Initial IT Infrastructure Assessments, Qualification Project Plans/Summaries, Test Plans/Summaries, Platform Requirement Specification with subsequent Functional Risk Assessments, Design/Configuration Specifications Trace Matrix, Qualification Protocols (IQ/OQ) and scripts, Testing Defects, etc.
- Support the development of IT Administrative SOP's for the infrastructure component/platforms, with ITQA and IT Teams.
- Oversee and coordinate the infrastructure component/platform test execution efforts.
- Support IT department personnel in navigating through and participating in the GxP Document Management Process (EDMS – Qumas DocCompliance) including coordinating workflow approvals.
- Support the refinement/implementation of the IT Infrastructure Qualification Programs.
- Support IT department in navigating through and participating in the GxP Change Control Process (including support/review of test plans.)
The Candidate must:
- Bachelor's Degree (BS/BA) from an accredited college or university.
- 7+ Years ITIQ experience is required. 10+ years desired.
- Understanding of the GxP and the IT role in support of GxP compliance is required.
- Understanding of GAMP5 and risk based approach to validate/qualification is required.
- Ability to execute based on defined, but not elaborate, quality framework.
- Thorough understanding of IT CSV and IT QA Roles, responsibilities and interactions is required.
- Ability to identify, define and propose the quality framework based on daily challenges.
- Excellent communication and technical writing skills required.
- Detail oriented but focused on efficiency and workable solutions.
- Strong project management and organizational skills.
- Experience in IT Infrastructure requirements/design, deployment and IT Infrastructure Qualification
- Experience working in a FDA regulated environment with high emphasis on Validation/Qualification & Regulatory Compliance of infrastructure component/platforms and processes.
*This position requires the applicant to sit at the Tarrytown, NY site for most of the project. There will be some availability to work remotely.
Schedule: M-F flexible schedule with core hours 9-4 (40hrs/week with OT generally approved)
Length of Assignment: 1 Year +