DEPT: IT Quality & Regulatory Compliance
I. GENERAL SUMMARY:
The IT Analyst supports the IT Quality & Regulatory Compliance operation, team members and major system development life cycle activities, including validation review and change control approval of IT systems. Reports to: Abner Vazquez, Manager of IT Quality & Regulatory Compliance
II. PRINCIPAL DUTIES & RESPONSIBILITIES:
• Administer ITQ processes, manage team meetings and action register
• Support ITQ team in the review of system life cycle deliverables and activities that ensure regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.
• Assist in the development of IT Controls.
• Support administration of IT training records database
III. JOB DEMANDS:
This job requires the IT Analyst to attend department and project meetings, administer essential tasks related to IT Training, and other ITQ processes. The IT Analyst must maintain a professional manner in representing ITQ and in working with its customers and associates. The IT Analyst should demonstrate initiative and self-direction while also knowing when to seek assistance. This person must also be able to routinely schedule and complete multiple tasks and be timeline driven.
IV. JOB IMPACT:
The IT Analyst role provides a valuable service to ITQ, IT and Biogen in maintaining procedures and systems that are compliant with both regulatory (e.g., FDA) and corporate requirements and good business practices.
• Knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelines
• Experience performing Risk Assessments
• Experience on Risk based validation approach
• Experience validating SAAS solutions
• Excellent communication skills, both verbal and written
• Detailed knowledge on Data Integrity Requirements
• Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment
• Experience administering processes, scheduling and managing team meetings, and following up on action items
• Experience with MS Word, Excel, Outlook and other business software programs
• Experience with training records and document management systems
• The ability to work both independently and with teams at various levels in the organization
• Excellent organizational skills and attention to detail and accuracy
• Seven or more years of experience in computerized system validation within a regulated environment