Computer System Analyst

About PSC Biotech

Who are we

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client's expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Role Overview

We are seeking a detail-oriented SAP Computer System Validation (CSV) Analyst to support validation activities within a GxP-regulated environment. This role focuses on reviewing SAP test scripts, ensuring regulatory compliance, maintaining traceability, and supporting audit readiness.

You will collaborate closely with QA, IT, and business stakeholders to ensure validation deliverables align with FDA regulations, GAMP 5 guidelines, and CSV best practices, while applying a risk-based approach to testing and documentation.

Key Responsibilities:

• Review pre-executed SAP GxP test scripts for completeness, clarity, and alignment with requirements.
• Review post-executed test scripts to ensure accuracy, appropriate evidence, proper documentation of deviations, and approvals.
• Support and manage the test deviation process, ensuring proper documentation and resolution.
• Apply risk-based validation methodologies to test script development and execution.
• Ensure all documentation complies with:
• FDA 21 CFR Part 11
• EU Annex 11
• GAMP 5
• ALCOA+ principles
• Client-specific validation procedures
• Maintain end-to-end traceability across URS, FRS, test scripts, and test results.
• Collaborate with QA, IT, and business teams (including US stakeholders) during validation cycles and audit readiness activities.

Required Qualifications & Experience

• 3+ years of experience in SAP CSV or SAP QA within a GxP-regulated environment (pharmaceutical experience preferred).
• Strong knowledge of:
• FDA regulations
• Computer System Validation (CSV) and Computer Software Assurance (CSA) practices
• Hands-on experience with SAP modules such as:
• SD, MM, PP, QM, WM, EWM
• Experience with test management tools, such as:
• HP ALM
• SAP Solution Manager (SolMan)
• Jira
• Excellent attention to detail and high standards for documentation quality.

Key Skills & Competencies:

• Strong analytical and problem-solving skills
• Effective cross-functional collaboration
• Clear documentation and communication abilities
• Understanding of compliance and audit expectations
• Ability to work in a structured, process-driven environment

Shift Timing :Mon-Fri, 16:30 PM - 01:30 AM IST