Business Architect

Overview

A Computerized System Validation (CSV) professional who ensures compliance and validates computerized systems within a GxP-regulated pharmaceutical environment, authoring validation documentation and mentoring teams on regulatory standards.

What you'll do

• Draft, evaluate and peer-review validation documentation in strict accordance with Good Documentation Practices (GDP).
• Execute and oversee compliance and validation procedures for computerized systems.
• Coach and guide team members to apply client workflows and project validation goals consistently.

What you'll need

• Must have: Computer System Validation (CSV) skills.
• Minimum 3 years of experience is required in the source's basic requirements; the additional information states a minimum of 5 years of experience.
• Expertise in pharmaceutical regulatory compliance and computerized system validation (CSV).
• Strong practical background in GxP environments, including the complete validation lifecycle and the V-Model framework.
• Deep understanding and application of Good Documentation Practices (GDP).
• Thorough familiarity with GAMP5 industry standards and FDA regulatory guidelines, including FDA 21 CFR Part 11 compliance.
• Proven experience managing the end-to-end validation lifecycle for highly regulated projects.
• Excellent analytical capabilities and strong interpersonal communication skills.
• Highly effective problem-solving and troubleshooting abilities.
• Bachelor of Engineering (BE) degree or an equivalent academic credential.
• 15 years of full-time education is required.

Details

• Based at the Bangalore office.