Description
Duties include:Electronic Quality Management System Implementation Support
- Support the design and build stage of the implementation process of a Quality Management System for a deviation system, change control system, product complaint system and audit system.
- Responsible for the requirement analysis, design configuration, development, testing and documentation for the MetricStream Quality Solutions for the Quality Management System.
- Create and update system requirement specification, system design specification and requirements traceability matrix for computer system validation documentation deliverables.
- Create supporting Standard Operating Procedures (SOPs) for Quality System use, maintenance and administration.
- Participate in project teams that support the implement of the Quality Management System.
- Develop and execute test scripts.
- Perform in-depth system and process testing.
- Identify and track bugs in the design and build phase of the project.
Background:
- Minimum of 5 years of experience in a computerized systems environment preferably in a regulated industry.
- Proficient in the use of computerized systems
- Proficient in report development utilizing MetricStream reporting engine or business intelligence tools like Crystal Report, Business Object, Spotfire or Tableau.
- Strong knowledge of FDA guidelines and regulations regarding cGMPs
- Strong knowledge of FDA 21 CFR Part 11 requirements for computerized system
Please be in contact as soon as possible! This competitive role will fill quickly.
To find out more about Real please visit www.realstaffing.com