Manufacturing BA

Qualifications:

• Excellent Communication Skills
• Good Documentation Skills
• Real-time experience in requirement gathering, gap analysis, and converting them into user stories.
• Understand the regulatory requirements in the Manufacturing area.
• Liaise between Business User group and Technical / Solution Team.
• Ability to develop and deliver
• Stakeholder Analysis.
• Business Analysis Plan.
• Current State Analysis.
• Scope Statement Specification.
• Functional Requirements Specification.
• Wireframes and Other Visual Documentation.
• Information or Data Model Documentation.
• Test Plans, Test Cases, or User Acceptance Test Plans.
• Responsible to liaise with shop floor supervisors to understand their end to end Business process that includes tracking device history records for the materials that are produced, product handling procedures, shop floor digitalization, recoding the measurements, capture validation and Audit requirements. Help them with a solution to digitize their data entry that is handled today in a paper-based forms

Required Skills:

• MBA degree
• 7 to 9 of Total experience in IT industry and related field.
• 6 to 8 years of Business Analyst Experience in Life Science Domain in the Manufacturing area.
• Experience in Gather/understand the business requirements, analyze the requirements, carry out Fit Gap analysis, and prepare the Business requirement document or User Stories.
• Experience and good understanding on Good Manufacturing Practices, 21 CFR Part 11, and related regulatory requirements.

Desired Skills:

• Domain experience in Life Science, Pharma / Medical Devices.
• Exposure to Validation requirements
• Stakeholder Management and Project Management Skills