KPI DOCUMENT - SPECIALIST (DOCUMENTATION & VALIDATION)

Exp: 2- 4 Years

Location: Thane

Should be willing to travel with Project Team whenever required.

Role Objective

The Documentation & Validation Specialist is responsible for preparing and maintaining all technical and validation documents (DQ, IQ, OQ, PQ), supporting validation activities, and compiling complete handover files for clients. The role ensures project compliance, quality, and proper closure.

1. DOCUMENT PREPARATION - DQ/IQ/OQ/PQ

1. The individual shall prepare Design Qualification (DQ) documents as per project specifications.
2. The individual shall prepare Installation Qualification (IQ) documents, ensuring all equipment and systems meet specifications.
3. The individual shall prepare Operational Qualification (OQ) protocols and documentation, validating system functionality.
4. The individual shall prepare Performance Qualification (PQ) protocols and execute as per validation plans.
5. The individual must ensure all validation documents are complete, accurate, and approved before submission.
6. The individual shall maintain version control and proper filing of all documents.

2. VALIDATION SUPPORT

1. The individual shall support on-site and off-site validation activities.
2. The individual must ensure correct execution of validation protocols under guidance from Project Lead/Design Lead.
3. The individual shall document validation results accurately.
4. The individual shall highlight deviations, issues, or non-conformance immediately to Project Lead.
5. The individual shall follow up on corrective and preventive actions (CAPA) if required during validation.

3. HANDOVER PACKAGE PREPARATION

1. The individual shall prepare complete handover files for clients, including:

• DQ/IQ/OQ/PQ documents
• Manuals
• As-built drawings
• Compliance certificates

1. The individual must ensure accuracy, completeness, and professional presentation of the handover package.
2. The individual shall coordinate with all teams (Project, Supply Chain, Field, Design) to gather required documents.
3. The individual shall ensure timely submission of handover package to the client.

4. DOCUMENT CONTROL & ORGANIZATION

1. The individual shall maintain properly organized and structured document libraries.
2. The individual must ensure all documents are easy to access, traceable, and auditable.
3. The individual shall ensure compliance with internal and client standards for documentation.
4. The individual must maintain digital and physical copies of critical documents.

5. COORDINATION WITH INTERNAL TEAMS

1. The individual shall coordinate with:

• Project Delivery Lead
• Design & Planning Lead
• Field Engineers & Technicians
• Supply Chain

1. The individual must ensure all inputs required for validation and documentation are received on time.
2. The individual shall communicate any gaps or missing documents immediately.

6. QUALITY & COMPLIANCE

1. The individual shall ensure documents are technically accurate and comply with industry standards.
2. The individual must follow company-approved SOPs for validation and documentation.
3. The individual shall support internal and client audits related to documentation.

7. TIMELINE & DEADLINE MANAGEMENT

1. The individual shall ensure timely preparation of all validation protocols.
2. The individual must ensure handover package is ready before project closure deadlines.
3. The individual shall prioritize tasks based on project criticality and client timelines.

8. TRAINING & SKILL DEVELOPMENT

1. The individual shall continuously improve knowledge of validation protocols and regulatory requirements.
2. The individual must stay updated on industry best practices for documentation and compliance.
3. The individual shall aim to grow into a senior validation/documentation role in the company.

9. ISSUE IDENTIFICATION & ESCALATION

1. The individual shall identify incomplete or incorrect documents and escalate to Lead immediately.
2. The individual must report validation or compliance issues promptly.
3. The individual shall provide solutions or suggestions to resolve documentation gaps.

10. PERFORMANCE EVALUATION CRITERIA

The Documentation & Validation Specialist will be evaluated based on:

• Accuracy and completeness of DQ/IQ/OQ/PQ documents
• Timely preparation and submission of handover files
• Compliance with SOPs and industry standards
• Coordination with teams for documentation inputs
• Support in validation activities
• Audit readiness and professional documentation presentation

experience