What are the responsibilities and job description for the Application Analyst -Trackwise position at TribolaTech Inc?
Trackwise Systems Application Analyst is a seasoned professional with complete and in-depth conceptual and practical knowledge of Trackwise Digital platform. The candidate will lead delivery of system improvements and small to moderate projects with minimal guidance and direction. It involves:
• Collecting business requirements and analyzing impacts on the existing solution
• Applying knowledge of Trackwise’s best practices to internal processes to make recommendations for system design.
• Developing and configuring new and existing processes including analyzing business processes, evaluating user requirements and system specifications, process flows, group categories, terminology, states and activities, permissions, login accounts, record types and settings.
• Supporting business users during User Acceptance Tests execution.
• Working on issue resolution, coordinating with support teams or vendors when necessary.
• Creating validation deliverables such as test scripts, User Requirements Specification document, Functional/Technical Requirements Specification and Configuration Specification documentation following Integra’s Computer System Validation and Change control process.
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
• BA/BS degree in Computer Science or Software Engineering.
• 8 years of relevant experience in pharmaceutical/medical device industry. 4-5 years of proven experience in an business quality systems environment.
• Technical knowledge of Trackwise Digital system with previous experience on Non Conformance Trackwise Digital modules is a must-have. Expertise in Supplier Quality Management Module is a nice to have.
• At least, involvement in one Trackwise Digital project implementation from project planning to go live.
• Knowledge of GxP, GAMP5, 21CFR Part11 and industry best practices.
• Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practices.
• Strong written and verbal communication skills ensuring the ability to interact with the business, peers and vendors in a professional manner.
• Ability to work well with culturally and geographically diverse teams
• Ability to work independently with minimal supervision.
