Principal Business Analyst - TrackWise (Softworld_231601) Billerica, Massachusetts
Job Number: 231601
Principal Business Analyst - TrackWise
Softworld’s client is hiring a Principal TrackWise Business Analyst to join the team. The Pr. Business Analyst is responsible to deliver high-quality requirements for all Trackwise projects. S/He will follow Agile methodologies for project governance, leverage BA tools & techniques to capture business and functional requirements, create user stories, and Epics.
Responsibilities
Coordinate the technical needs to create business and technical requirements documents – Requirement Specifications
Coordinate project meetings, communicate with the team, internal/external partners and senior management
Participate in scoping, white-boarding sessions, establish the as-is and to-be state working with stakeholders and partner with them to identify, prioritize opportunities for business process optimization, IT implementation to achieve goals.
Ability to work with IT teams, explain the business requirements in detail to translate the technical terms.
Work with business teams to define the User Acceptance Test criteria, help business in defining User Acceptance test scenarios.
Work with Dev, QA teams in explaining the business requirements, translate into reporting functional requirements.
Design and implement deployment architectures to deploy large scale software suites incrementally across multiple geographies.
Influence architecture, standards and & process to ensure reliability, uptime, performance and scale.
Identify gaps in current technology and processes and recommend improvements
Working with agile team involving scrum and sprint planning sessions
Work with Business to write Epics and User stories and lead Backlog grooming sessions
Perform TrackWise product installation and Upgrade
Develop technical solutions using the core TW product and utilities - Create workflows, Business rules, TWC automation, Notifications and Migrate updates
Develop and Implement Crystal Reports & QualityView
Prepared validation documents System Config/Design Specification (SDS) documents, perform Unit Testing, IQ & OQ Documents
Assist in preparing the OQ test scripts and provided support and guidance for OQ and PQ execution
Plan and execute the cutover and project Go-LIVE activities
Transition the knowledge to Operations team for post Go-LIVE
Delivering Response and Estimation for projects and enhancements
Familiar with Quality Business Process like Audit, CAPA, Change Management and Risk Management etc.
Good knowledge of Software Development Life Cycle
Manage Environments Life Cycle & Releases
Qualifications
12+ years of experience in large enterprise systems with rich business analysis and requirements gathering specific to complex integrated systems especially TrackWise application
10+ years of experience in conducting business requirements sessions, writing business requirements and developing use cases
Minimum 5+ years of experience in any of tool (JIRA)
Expert in MS Office tools including MS Visio, MS Excel, MS PowerPoint
Strong knowledge SDLC and RICEFW processes, working experience of Onsite – Offshore model and with highly cross functional teams
Prior experience in a large IT organization within the Pharma or Clinical space
Excellent communication skills (written and verbal)
Exceptional knowledge of business processes and willingness to constantly update knowledge.
Demonstrate skills in understanding client needs and treat client not only a customer but also an internal team
Communication skills, problem-solving skills, and knowledge of industry best practices to guide the mid and junior level BA team on issues related to business requirements
Have oversight and provide feedback on how the team is following business analyst best practices
Inbuilt ability to multi-task, working on more than one issue simultaneously.
Have strong commitment to customer service and operational excellence.
Conflict resolution as it relates to people and project priorities
Able to take the initiative and carry out tasks independently.
Understanding of financial and accounting regulatory and reporting requirements: experience in forecasting, budgeting and financial analysis combined with understanding of KPIs
Understanding of Agile development and lifecycle processes and experience working within an Agile development process.
Good to have any industry standard BA certification like CBAP, PMI PBA, EXIN BCS BA etc
Good Understanding of TrackWise Product
Experience working in the Life Sciences domain specifically in Quality and regulatory space. Have worked for major Pharmacy and Medical Device clients
Knowledge of GxP operations: Audit Management (both GMP and Regulatory Compliance), Incident Management, Corrective and Preventive Action (CAPA), Change Management, Risk management and Project Quality Management (Standardized and risk-based Quality Evaluations)
Prepared validation documents workflow, System Config/Design Specification (SDS), Functional requirements (FRS), Report Specification documents.
Assist in preparing the OQ test scripts and provided support and guidance for OQ and PQ execution
Assist in the development of training materials and user guide documents.
Use automated requirements management tools, ensure computer system validation and industry best practices are followed for software application and interface implementations.
Generate validation documentation deliverables to maintain project compliance.
Consults and coordinates with the business to design and develop process improvement.
Participate in the UAT dry run and UAT execution to help cross verify the requirements
Establishing backlog and categorize according to module and business needs to help execute development
Familiar with Quality Business Process like Audit, CAPA, Change Management and Risk Management,
Should have a high-level understanding using the core TW product and utilities -Data Types, workflows, Business rules, TWC automation, Notifications and Crystal Reports & QualityView
THIRD PARTY AGENCIES, SUBCONTRACTORS, AND RECRUITERS NEED NOT APPLY. Applicants received from firms will not be considered. Subcontracting is not available for this position.