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Posted 08 July, 2026

Computer System Validation

VARITE INDIA PRIVATE LIMITED
Hyderabad, Telangana, IN Full Time
Reference: 26-37425-2522-2

Company Name: VARITE India Private Limited

About The Client:

Client is an Indian multinational technology company specializing in information technology services and consulting. Headquartered in Mumbai, it is a part of the Tata Group and operates in 150 locations across 46 countries.

Essential Job Functions:
Computer System Validation
  • Plan, execute, and maintain validation activities for GxP relevant computerized systems in accordance with regulatory and internal quality requirements.
  • Develop and review validation deliverables including:
    • Validation Plans
    • User Requirements
    • Risk Assessments
    • Test Protocols
    • Test Scripts
    • Traceability Matrices
    • Validation Summary Reports
  • Ensure validation activities demonstrate that systems are fit for intended use, reliable, and operate in a controlled environment.

Risk Based Approach & Compliance

  • Apply risk based validation principles aligned with regulatory expectations (e.g., GxP, Part 11, ISO 13485).
  • Support audits and inspections by providing clear, complete, and compliant validation documentation.
  • Assess impact of system changes and support re validation activities as required.

Change & Configuration Management

  • Ensure validated systems remain in a compliant state through effective change control and configuration management.
  • Review system updates, patches, and enhancements to determine validation impact.
  • Maintain system inventory and validation status throughout system lifecycle.

Cross Functional Collaboration

  • Work closely with IT, Quality, Engineering, Vendors, and Business stakeholders to support validation activities.
  • Participate in system implementation projects to embed validation from early lifecycle stages.
  • Support training and awareness on CSV processes and regulatory expectations
Qualifications:
  • In-depth understanding of Computer System Validation (CSV) and Computer Software Assurance (CSA).
  • Understanding SDLC and its various phases/stages.
  • Understanding and Expertise in Risk Management (ICH Q9 and ICH Q8).
  • Understanding of GAMP categories.
  • Understanding of Industry Standards like ISO 13485.
  • Understanding on QMS and regulations like 21 CFR Part 820.
  • Understand GSM (SDLC) methodology and different procedures to implement it.
  • Understanding and implementation expertise of CSV deliverables.
  • Provide consultations to project teams on how to implement validation as appropriate for the selected S/W Validation approach.
  • Recommend project teams which validation approach might be more suitable for them.
  • Understand SOP and Work Instructions and guide project teams on how to create deliverables.
  • Understand Regulatory compliance like PI/PHI, ERES (21 CFR Part 11) to the extent to provide consultation when required.
  • Expertise on change management process and Provide consultation to implement Software changes.
  • Review and Approve Validation deliverables and System changes.

Essential Skills

  • Computer System Validation (CSV) Specialist / Analyst.

Desirable Skills

Keyword

Skills

  • Life Sciences : Computer System Validation.

Experience Required

  • 6–8 Years.

How to Apply: Interested candidates are encouraged to respond/submit their updated resumes, and for additional job opportunities, please visit Jobs In India – VARITE.

Unlock Rewards: Refer Candidates and Earn.
If you're not available or interested in this opportunity, please pass this along to anyone in your network who might be a good fit and interested in our open positions. VARITE offers a Candidate Referral program, where you'll receive a one-time referral bonus based on the following scale if the referred candidate completes a three-month assignment with VARITE.

Experience Level Bonus Referral:
0-2 years INR 5,000
2-6 years INR 7,500
6+ years INR 10,000

About VARITE: VARITE is a global staffing and IT consulting company providing technical consulting and team augmentation services to Fortune 500 Companies in USA, UK, CANADA and INDIA. VARITE is currently a primary and direct vendor to the leading corporations in the verticals of Networking, Cloud Infrastructure, Hardware and Software, Digital Marketing and Media Solutions, Clinical Diagnostics, Utilities, Gaming and Entertainment, and Financial Services.

Equal Opportunity Employer:
VARITE is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, marital status, veteran status, or disability status.

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