Remote GMP AI Workflows SME - Pharma Manufacturing & QA

Smart Caliber Technology; United States; Teletrabalho; USD 83 000 - 152 000; Tempo integral

Resumo da oferta

Smart Caliber Technology seeks a Pharma Manufacturing SME to guide AI-enabled workflows in GMP settings. This 3–4 month, 100% remote engagement focuses on deviation/CAPA triage, autonomous batch record review, and TMF/inspection readiness.

The role validates workflows against real-world manufacturing and quality practices, ensuring human oversight and regulatory alignment. The ideal candidate has senior GMP operations experience, strong knowledge of QA processes, and hands-on exposure to Veeva

Qualificações

• Advise on streamlining deviation and CAPA logging.
• Validate evidence requirements for quality records and escalation decisions.
• Review escalation pathways and sponsor notification tracking.
• Identify opportunities and limitations for AI-assisted quality event management.

Responsabilidades

• Validate proposed AI workflows against real-world GMP manufacturing and QA practices.
• Define regulatory and human-in-the-loop boundaries for AI-enabled processes.
• Sanity-check workflow assumptions, feasibility, and cycle-time improvements.
• Provide SME feedback from hands-on pharma manufacturing and quality operations.
• Identify risks and gaps not apparent from a purely technology perspective.

Conhecimentos

Deviation & CAPA triage

Autonomous batch record review

TMF / inspection readiness

Descrição da oferta de emprego

Smart Caliber Technology seeks a Pharma Manufacturing SME to guide AI-enabled workflows in GMP settings. This 3–4 month, 100% remote engagement focuses on deviation/CAPA triage, autonomous batch record review, and TMF/inspection readiness.

The role validates workflows against real-world manufacturing and quality practices, ensuring human oversight and regulatory alignment. The ideal candidate has senior GMP operations experience, strong knowledge of QA processes, and hands-on exposure to Veeva