The IT Compliance Analyst is responsible for ensuring that the IT group is operating in compliance with regulatory requirements and internal procedures.

Essential Duties and Responsibilities include, but are not limited to, the following:
• 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 Quality Assurance personnel and the Quality Management System
• Evaluates, develops and modifies 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 and maintained in a validated state
• Represents IT or assists IT SME’s during in 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 SME’s with IT Change Controls
• Ensures IT Training is adequate and current
• Completes GAP assessments and remediation efforts
Education and Experience:
• BS/BA in related field and a minimum of 5 years relevant experience preferred; will substitute relevant industry experience for educational requirement.
• Strong preference for QA experience within an IT department
• 3 years of pharmaceutical or biotechnology experience.

Knowledge and Skills:
• Knowledge of cGMP, 21 CFR Part 11, Annex 11, GAMP 5
• Knowledge and experience of Quality Management Systems
• Knowledge and experience of SDLC methodologies in a cGMP regulated environment
• Working knowledge of utilizing a risk-based approach to documentation and/or experience with Quality Risk Management is strongly preferred
• Excellent technical writing ability and communication skills
• Excellent attention to detail, computer skills, and ability to adapt to new systems/technologies

Email me jobs like this