GMP & GxP Business Analyst

Overview

Remote
Depends on Experience
Contract - W2
No Travel Required

Skills

GxP
Wearables/XR
Digital Twins
AI
Pharma IT
Pharmaceutics
Artificial Intelligence

Job Details

Role : GMP & GxP Business Analyst

Location : Remote

W2 Only
 
Note: Must have Pharmaceutical or Healthcare Experience
 

Roles & Responsibilities:

  • Collect data, analyse & define the business and user requirements
  • Point of contact and between business, IT, end user and other cross functional teams during the project or maintenance phase.
  • Analyse business problems and facilitate in IT solution evaluation.
  • Work closely with managers and end users to have buy-in for the proposed solution.
  • Creating a detailed business analysis, outlining problems, opportunities, and solutions for the business users and stakeholders.
  • Categorize the functional and non-functional requirements of the business.
  • Conduct post project implementation acceptance and requirements reviews.
  • Perform additional tasks as assigned by the reporting manager, time-to-time basis in DevOps mode.
  • Prepare validation documentation related to release of GxP system. Should have sound knowledge on preparing validation artifacts for GxP IT systems.
  • Should have knowledge of GxP system testing and validation.
  • Sound communication skill with good amount of convincing power (intermediate level).
  • An ideal candidate should be well planned and structured in his/her all deliverables.
  • Must have experience in Pharma IT with hands-on expertise for handling GxP systems

 

Qualifications:

  • Bachelor's in Engineering or Master's degree in a related discipline, including a minimum of 10-12 years of experience gained in technology implementation in the Pharma space
  • Specific experience as a Business Analyst in a GxP application for a pharma company
  • Excellent oral/ written communication skills
  • Self-starter, with the ability to work and execute independently with minimal oversight
  • Good to have working knowledge in AI, Wearables/XR and/ or Digital Twins
 
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