Pharmaceutical AI Specialist

Sweya Information Technologies LLP; Philadelphia (Philadelphia County); On-site; USD 90,000 - 120,000; Full time

Job summary

Sweya Information Technologies LLP in the United States seeks a specialist to deploy AI solutions in pharmaceutical settings, focusing on compliance, process automation, and automated audit preparation.

You will implement document compliance validation agents, ensure systems meet FDA 21 CFR Part 11 and EU GMP standards, and configure automated pharmacovigilance monitoring loops. You will also lead customer workshops on compliant auditing workflows.

Qualifications

• Experience implementing FDA 21 CFR Part 11 compliant systems.
• Knowledge of pharma regulatory guidelines and validation processes.
• Ability to validate systems and write test scripts in Python.

Responsibilities

• Deploy AI solutions for document compliance validation.
• Ensure systems comply with FDA 21 CFR Part 11 and EU GMP.
• Configure automated safety monitoring loops.
• Conduct customer workshops on compliance auditing workflows.

Skills

Pharma Regulatory Guidelines

FDA 21 CFR Part 11

System Validation

Python

Job description

Deploy AI solutions in pharmaceutical companies, focusing on compliance, process automation, and automated audit preparation.

Key Responsibilities

• Deploy specialized agents for document compliance validation.
• Ensure systems meet FDA 21 CFR Part 11 and EU GMP standards.
• Configure automated safety monitoring (pharmacovigilance) loops.
• Conduct customer workshops on compliance auditing workflows.

Required Technical Skills

• Pharma Regulatory Guidelines
• FDA 21 CFR Part 11
• System Validation
• Python