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.
- DOCUMENT PREPARATION – DQ/IQ/OQ/PQ
- The individual shall prepare Design Qualification (DQ) documents as per
project specifications. - The individual shall prepare Installation Qualification (IQ) documents,
ensuring all equipment and systems meet specifications. - The individual shall prepare Operational Qualification (OQ) protocols and
documentation, validating system functionality. - The individual shall prepare Performance Qualification (PQ) protocols and
execute as per validation plans. - The individual must ensure all validation documents are complete, accurate,
and approved before submission. - The individual shall maintain version control and proper filing of all
documents. - VALIDATION SUPPORT
- The individual shall support on-site and off-site validation activities.
- The individual must ensure correct execution of validation protocols under
guidance from Project Lead/Design Lead. - The individual shall document validation results accurately.
- The individual shall highlight deviations, issues, or non-conformance
immediately to Project Lead. - The individual shall follow up on corrective and preventive actions (CAPA) if
required during validation. - HANDOVER PACKAGE PREPARATION
- The individual shall prepare complete handover files for clients, including:
DQ/IQ/OQ/PQ documents
Manuals
As-built drawings
Compliance certificates - The individual must ensure accuracy, completeness, and professional
presentation of the handover package. - The individual shall coordinate with all teams (Project, Supply Chain, Field,
Design) to gather required documents. - The individual shall ensure timely submission of handover package to the
client. - DOCUMENT CONTROL & ORGANIZATION
- The individual shall maintain properly organized and structured document
libraries. - The individual must ensure all documents are easy to access, traceable, and
auditable. - The individual shall ensure compliance with internal and client standards for
documentation. - The individual must maintain digital and physical copies of critical documents.
- COORDINATION WITH INTERNAL TEAMS
- The individual shall coordinate with:
Project Delivery Lead
Design & Planning Lead
Field Engineers & Technicians
Supply Chain - The individual must ensure all inputs required for validation and
documentation are received on time. - The individual shall communicate any gaps or missing documents
immediately. - QUALITY & COMPLIANCE
- The individual shall ensure documents are technically accurate and comply
with industry standards. - The individual must follow company-approved SOPs for validation and
documentation. - The individual shall support internal and client audits related to
documentation. - TIMELINE & DEADLINE MANAGEMENT
- The individual shall ensure timely preparation of all validation protocols.
- The individual must ensure handover package is ready before project closure
deadlines. - The individual shall prioritize tasks based on project criticality and client
timelines. - TRAINING & SKILL DEVELOPMENT
- The individual shall continuously improve knowledge of validation protocols
and regulatory requirements. - The individual must stay updated on industry best practices for documentation
and compliance. - The individual shall aim to grow into a senior validation/documentation role in
the company. - ISSUE IDENTIFICATION & ESCALATION
- The individual shall identify incomplete or incorrect documents and escalate to
Lead immediately. - The individual must report validation or compliance issues promptly.
- The individual shall provide solutions or suggestions to resolve documentation
gaps. - 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
Company: Acme HR Consulting
Experience: 2–4 years
Location: Thane
Employment Type: Full-time
Salary: Negotiable (based on experience & skills)
How to Apply
Send your updated resume to:
acmetalenthunt1@gmail.com
siyaacmehr@gmail.com
Contact Us
79866-94813
79866-43012

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