Job Description
Job Role: IT Quality Analyst
Responsibilities:
- Approve system life cycle deliverables (SDLC} and activities to ensure that regulations, protocols, procedures, and methodologies are followed
- Ensure that appropriate and complete documentation is captured and reported to support validation activities
- Represent IT Quality on cross-functional teams with IT R & D in support of SDLC activities
- Consult on the authoring and conformance of validation-related deliverables and activities in regards to corporate SOPs and current regulations
- Provide guidance, training and support to IT personnel in their validation efforts, to ensure compliance
- Provide quality assurance oversight for system related issues (Test incidents, issues, etc.)
- Advise technical personnel and project teams on regulatory compliance and interpretation and recommend appropriate corrective actions where needed
- Attend department and user meetings, system assessment meetings, trainings, and other essential tasks
- Maintain a professional manner in representing the company and in working with its agents and associates
- Demonstrate initiative and self-direction while also knowing when to seek assistance
- Bachelor's or Master's Degree
- Ability to routinely schedule and complete multiple tasks and be timeline driven
- At least 7 years IT Quality / Validation experience in computerized system validation within a regulated environment preferably R & D application
- Thorough knowledge of GxP and ERES (21CFR Part 11 and Annex 11) regulations and guidelines
- Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment
- Thorough knowledge of IT Controls methodologies, including GAMPS and ITIL
- Experience with risk analysis and risk management practices and tools
- Excellent communication skills, both verbal and written
- Knowledge of general software, database concepts and Data Integrity
- Knowledge of infrastructure technology and platforms
- The ability to work both independently and with teams