Documentation Lead – Validation & Regulatory Documents

DGXPComplianceLab; Hyderabad; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

DGXPComplianceLab seeks a Documentation Lead to own the quality and consistency of validation, quality and regulatory documentation across client programmes in Hyderabad. You will shape standards, templates and review workflows, ensuring accuracy and readiness for audits.

You will lead the documentation team, allocating writing tasks, approving key deliverables and training staff on GDP and regulatory writing standards.

Qualifications

• 10–14 years in pharmaceutical documentation or regulatory writing
• Led documentation teams or programmes
• Strong command of GxP, CTD structure and data integrity
• Excellent review and editing skills

Responsibilities

• Own the quality and consistency of all project documentation across validation, quality and regulatory work
• Lead the documentation team and allocate writing assignments
• Set templates, standards and review workflows
• Approve key validation, quality and regulatory deliverables
• Prepare documentation packages for audits and submissions
• Train writers and reviewers on GDP and writing standards

Skills

Documentation leadership

Regulatory writing

GxP/CTD knowledge

Editing & review

Tools

eDMS

Job description

Documentation Lead – Validation & Regulatory Documents

Own the quality and consistency of all project documentation across validation, quality and regulatory work.

• Lead the documentation team and allocate writing assignments
• Set templates, standards and review workflows
• Approve key validation, quality and regulatory deliverables
• Prepare documentation packages for audits and submissions
• Train writers and reviewers on GDP and writing standards

Required skills

• 10–14 years in pharmaceutical documentation or regulatory writing
• Led documentation teams or programmes
• Strong command of GxP, CTD structure and data integrity
• Excellent review and editing skills

Preferred skills

• Experience with eDMS implementation
• Structured authoring / content reuse

Project / industry exposure

• Multiple client programmes and inspection readiness