Description:
Essential Duties & Responsibilities:
- Ensures IT procedures are in compliance with regulatory and corporate requirements
- Ensures IT personnel are operating in compliance with regulations and procedures
- Assists IT personnel in interactions with QA personnel & the Quality Management System
- Evaluates develop, and modify IT Policies and Standard Operating Procedures to meet regulatory requirements and obligations
- Provides IT with Technical Writing assistance
- Tracks and reports on IT Quality metrics
- Works closely with QA Validation to ensure IT systems are validated & maintained in a validated state
- Represents IT or assists IT SMEs during internal and external audits
- Ensures IT Operational Controls are in place and maintained throughout the system lifecycle e.g. Periodic Reviews, Disaster Recovery testing, Performance Monitoring, etc.
- Tracks that all IT Administration activities are completed as per procedures
- Champions Data Integrity for all IT systems
- Represents IT at NOE/Deviation/Event meetings
- Assists IT personnel in writing/responding to Deviation/Events including detailed event investigation and root cause analysis
- Tracks and facilitates the remediation activities associated with IT-related CAPAs
- Assists IT personnel in participating in and successfully navigating through the Quality Management Processes
- Manages or assists IT SMEs with IT Change Controls
- Ensures IT Training is adequate and current
- Completes GAP assessments and remediation efforts
Requirements
Education & Experience:
- BS/BA in the related field & a minimum of 5 years relevant experience preferred; will substitute relevant industry experience for the educational requirement.
- Strong preference for QA experience within an IT department
Knowledge & Skills:
- Knowledge of cGMP, 21 CFR Part 11, Annex 11, GAMP 5
- Knowledge & experience in Quality Management Systems
- Knowledge & experience of SDLC methodologies in a cGMP-regulated environment