CSV Lead / Validation Manager – Computerised Systems

DGXPComplianceLab; Hyderabad; On-site; INR 450,000 - 900,000; Full time

Job summary

DGXPComplianceLab is seeking a CSV Lead / Validation Manager – Computerised Systems to lead validation programmes and manage a team of CSV engineers across client projects. You will define strategy, master plans, risk approaches, and act as the point of contact for clients and auditors.

You will plan resources, timelines, and maintain the quality of validation deliverables, while mentoring staff and improving templates and methodologies. Experience with regulatory inspections is essential.

Qualifications

• 10–14 years of CSV experience with at least 4 years in leading teams.
• Hosted regulatory inspections or client audits experience.
• Deep knowledge of GAMP 5, Part 11, Annex 11 and data integrity.
• Stakeholder and project management skills.

Responsibilities

• Lead computerised-system validation programmes and a team of CSV engineers.
• Define validation strategy, master plans and risk approach.
• Act as the validation point of contact for clients and auditors.
• Plan resources, timelines and quality of validation projects.
• Mentor staff and improve validation templates and methods.

Skills

CSV experience (10–14 yrs)

Team leadership (4+ yrs)

Regulatory inspections

GAMP 5

Part 11

Data integrity

Job description

CSV Lead / Validation Manager – Computerised Systems

Lead computerised-system validation programmes and a team of CSV engineers across multiple client projects.

• Define validation strategy, master plans and risk approach
• Lead a team of CSV engineers and review deliverables
• Act as the validation point of contact for clients and auditors
• Plan resources, timelines and quality of validation projects
• Mentor staff and improve validation templates and methods

Required skills

• 10–14 years in CSV, including at least 4 years leading teams
• Hosted regulatory inspections or client audits
• Deep knowledge of GAMP 5, Part 11, Annex 11, data integrity
• Stakeholder and project management skills

Preferred skills

• Validation of AI-enabled or cloud (SaaS) systems