Contractor

Long Description

Responsibilities

• Liaise with Manufacturing, Regulatory Affairs and Packaging SMEs of a Lifesciences client.
• Conduct virtual workshops to discuss and capture requirements with SMEs
• Elicit and document business requirements utilizing a structured process of gathering, analyzing, documenting, and steering changes through the project processes.
• Develops, writes, and validates and communicates business requirements and use cases for the design and implementation of business and/or technology solutions. Ensures functional design meet the business requirements.
• Leads and provides direction for planning, design and execution of business requirements validation testing and user acceptance testing.
• Directs OCM and training strategy and plan based on stakeholder analysis
• Coordinate communication among various business groups and IT technical teams.
• Perform feasibility analysis, scopes projects, and works with the project management to priorities the deliveries
• Perform Requirement Analysis

Long Description

• Recommend business process and system changes to improve efficiency and business outcomes. Document current processes and propose future state processes
• Work with a diverse business community to document as-is and to-be business processes.
• Ensure clear communication between business stakeholders and IS technical teams.  
• Draft Product Label requirements documents and get it approved.
• Create Risk, Issue, Dependencies and Assumptions from the interactions
• Create Label project business case
• Create Label design project plan
• Support Label Developer and Label designer and IT teams with inputs on requirements.
• Test Labels against Specifications and against existing Labels in Legacy Systems.
• Responsible for timely deliverables of multiple concurrent analysis and development initiatives, in accordance with project and development standards.

Area(s) of responsibility

Qualifications and Skills:

• Strong interpersonal skills and ability to work in a team environment.
• Bachelor’s Degree in engineering or Industrial or related field with 4-6 years of experience on  Manufacturing/Labeling systems.
• Manufacturing domain experience, Medical device manufacturing a plus
• Experience on working on product Labels projects in Life Sciences industry.
• Experience with documenting complex processes and presenting them in a clear and understandable format
• Knowledge of Software Development Life Cycle in Life Sciences industry.
• Knowledge of Label verification in a medical device company
• Work with multiple teams and across time zones
• Domain knowledge on pharma manufacturing is desirable

Generic Managerial Skills

• Good communication skills
• Able to facilitate discussions with stakeholders
• Able to help junior team members
• Good planning and organizing skills
• Provide solution opti