Overview
Remote
Depends on Experience
Contract - W2
Contract - Independent
Skills
Acceptance Testing
Artificial Intelligence
Business Analysis
Collaboration
Communication
DevOps
Documentation
Evaluation
FRS
Functional Requirements
GxP
IQ
Negotiations
OQ
PQ
Pharmaceutics
Project Implementation
Regulatory Compliance
Reporting
Supervision
System Testing
URS
Job Details
GMP & GxP Business Analyst
Location: Remote
Duration: Long Term
Roles & Responsibilities
- Gather, analyze, and document business and user requirements across functional teams.
- Act as the primary liaison between Business, IT, end users, and cross-functional stakeholders during project execution and maintenance phases.
- Analyze business challenges and support evaluation of appropriate IT solutions.
- Collaborate with managers and end users to ensure alignment and buy-in for proposed solutions.
- Develop detailed business analysis documents outlining problems, opportunities, and recommended solutions.
- Identify and categorize functional and non-functional requirements.
- Conduct post-implementation reviews, UAT support, and requirement assessments.
- Perform additional DevOps-mode activities as assigned by the reporting manager.
- Prepare validation documentation for GxP system releases, including authoring validation deliverables such as URS, FRS, and IQ/OQ/PQ.
- Demonstrate strong understanding of GxP system testing, validation processes, and compliance standards.
- Communicate effectively with stakeholders and exhibit strong persuasion/negotiation capabilities.
- Ensure all deliverables are structured, planned, and executed with high quality.
- Possess hands-on experience in Pharma IT environments with exposure to GxP-regulated applications.
Qualifications
- Bachelor s degree in Engineering or a Master s degree in a related field.
- 10 12 years of technology implementation experience in the pharmaceutical domain.
- Proven experience as a Business Analyst supporting GxP applications in a pharma organization.
- Excellent verbal and written communication skills.
- Self-motivated and able to work independently with minimal supervision.
- Good to Have: Working knowledge of AI, Wearables/XR, and/or Digital Twin technologies.
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