Position Overview

We are seeking an experienced SAS Installation & Validation Consultant to support the installation, qualification, and validation of SAS software within a regulated GxP environment. The consultant will be responsible for assisting with software deployment on a Windows virtualized infrastructure and executing Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation (CSV) activities to ensure compliance with FDA and industry regulatory requirements.

This is a project supporting a pharmaceutical client and requires hands-on experience installing and validating SAS software platforms in validated environments.

Responsibilities

SAS Installation & Configuration

- Install and configure SAS software within Windows Server and virtual machine environments.
- Validate system prerequisites and infrastructure requirements.
- Coordinate with client IT and infrastructure teams during installation and setup.
- Troubleshoot installation and configuration issues.

Validation & Qualification Activities

- Develop and/or execute IQ/OQ protocols.
- Support Computer System Validation (CSV) documentation.
- Verify and document system functionality according to approved validation plans.
- Generate validation evidence and maintain complete audit-ready documentation.
- Support deviation investigation and remediation efforts.

Regulatory Compliance

- Ensure compliance with:
- FDA 21 CFR Part 11
- GAMP 5
- Good Documentation Practices (GDP)
- GxP regulations

- Participate in validation reviews and approvals.

Documentation

- Create and update:
- Validation Plans
- Risk Assessments
- Installation Qualification (IQ) protocols
- Operational Qualification (OQ) protocols




- Traceability Matrices
- Validation Summary Reports (VSR)

Required Qualifications

- 5+ years of Computer System Validation (CSV) experience.
- Hands-on experience installing and configuring SAS software.
- Experience validating software applications in regulated pharmaceutical, biotech, or medical device environments.
- Strong knowledge of:
- FDA 21 CFR Part 11
- GAMP 5
- Data Integrity requirements
- SDLC and Validation Lifecycle methodologies

- Experience with Windows Server environments.
- Experience working within virtual machine infrastructures (VMware, Hyper-V, Azure Virtual Desktop, or similar).
- Excellent technical troubleshooting and documentation skills.

Preferred Qualifications

- Previous experience supporting SAS Clinical, SAS Enterprise Guide, SAS Server, or SAS Analytics installations.
- Experience with cloud-hosted or virtualized environments.
- Familiarity with pharmaceutical quality systems.
- Prior consulting experience supporting validation engagements.
- Experience developing validation deliverables from templates and standards.

Deliverables

The consultant will be expected to provide:

- Completed SAS installation and configuration.
- Executed IQ documentation.
- Executed OQ documentation.
- Validation evidence package.
- Validation Summary Report.
- Resolution of installation-related issues.
- Knowledge transfer documentation.

Ideal Candidate

The ideal consultant has previously installed and validated SAS software in a regulated life sciences workplace and can independently perform both technical installation activities and validation execution. Experience supporting pharmaceutical clients during software qualification projects is strongly preferred.

📌 SAS Installation / Validation Consultant (IQ/OQ/CSV) (Hyderabad)
🏢 Qentelli
📍 Hyderabad