Business Process Architect

Overview

Business Process Architect role focused on computerized system validation (CSV) 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.
• Analyze and design new business processes and the documentation that guides their implementation.
• Partner with the business to define product requirements and use cases to meet process and functional requirements.
• Participate in user and task analysis to represent business needs.

What you'll need

• Computer System Validation (CSV) skills.
• Minimum 3 years of experience (the ad also states a minimum of 5 years of experience).
• Expertise in pharmaceutical regulatory compliance and computerized system validation.
• Strong practical background in GxP environments, 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 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 full-time education required.

Details

• Based at the Pune office.