Key Facts

Remote From:

Full time

Mid-level (2-5 years)

English

Hard Skills

SAP ERP FDA Regulations Regulatory Compliance JIRA Evidence Analysis SAP CO HP Computers SAP Solution Manager SAP EWM SAP FI Traceability Auditing Test Script Risk-Based Testing Deviation Investigations Good Documentation Practices

Other Skills

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Collaboration
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Communication
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Teamwork
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Detail Oriented

Roles & Responsibilities

3+ years of SAP CSV or SAP QA experience in a GxP regulated (pharma preferred) environment
Strong knowledge of FDA regulations, CSV and CSA best practices
Experience with SAP modules (SD/MM/PP/QM/WM/EWM) and test management tools (HP ALM, SolMan, Jira)
Excellent attention to detail and documentation quality

Requirements:

Review pre-executed SAP GxP test scripts for completeness, clarity, and alignment to requirements
Review post-executed test scripts for accuracy, proper evidence, deviations, and approvals
Maintain traceability across URS, FRS, test scripts, and results
Ensure documentation complies with FDA 21 CFR Part 11, Annex 11, GAMP 5, ALCOA+, and client validation procedures

PSC Biotech Corporation

Biotech: Biology + Technology

About PSC Biotech Corporation

Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. PSC Biotech Corporation serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has three unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, and BioTechnique™. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality. To learn more, visit our website.

Company type: SME

Industry: Biotech: Biology + Technology

Founded: 2018

Company size: 201 - 500

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Job description

This is a remote position.

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.

We are hiring a SAP Computer System Validation (CSV) Analyst to support validation activities within a GxP-regulated environment. The role focuses on reviewing SAP test scripts, ensuring compliance with regulatory standards, maintaining traceability, and supporting audit readiness. You will collaborate with QA, IT, and business teams to ensure validation deliverables meet FDA, GAMP 5, and CSV best practices while applying a risk-based approach to testing and documentation. Ideal candidates bring strong SAP CSV experience, attention to detail, and a solid understanding of validation frameworks.

Key Responsibilities
Review pre‑executed SAP GxP test scripts for completeness, clarity, and alignment to requirements.

Review post‑executed test scripts for accuracy, proper evidence, deviations, and approvals.
Support test deviation management process.
Understand risk based approach methodologies as it relates to test script development and execution.
Ensure documentation complies with FDA 21 CFR Part 11, Annex 11, GAMP 5, ALCOA+, and client validation procedures.
Maintain traceability across URS, FRS, test scripts, and results.
Collaborate with US QA, IT, and business teams on validation cycles and audit readiness.

Requirements

Qualifications

3+ years of SAP CSV or SAP QA experience in a GxP regulated (pharma preferred) environment.
Strong knowledge of FDA regulations, CSV and CSA best practices.
Experience with SAP modules (SD/MM/PP/QM/WM/EWM) and test management tools (HP ALM, SolMan, Jira).
Excellent attention to detail and documentation quality.
Shift Timing :Mon-Fri, 16:30 PM - 01:30 AM IST