CSV & GxP Compliance Lead | Pune

TransPerfect; Pune District; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

TransPerfect seeks a seasoned Computer System Validation and Regulatory Compliance Specialist to lead validation of technology platforms and services in a regulated environment. You will collaborate with IT, QA, development, and business teams to ensure systems affecting regulated data are validated and maintained per industry standards.

The role requires deep knowledge of GxP, GAMP 5, 21 CFR Part 11, and data integrity, with a track record of guidance through audits by FDA, EMA, or other

Qualifications

• Minimum 10 years of CSV experience in regulated industries (life sciences, healthcare, pharma).
• Deep understanding of GxP, GAMP 5, 21 CFR Part 11, and data integrity principles.
• Experience validating diverse systems (LIMS, ERP, eQMS, cloud platforms, SaaS).

Responsibilities

• Lead CSV activities across various GxP-regulated systems and applications.
• Ensure compliance with GAMP 5 and 21 CFR Part 11 requirements.
• Develop and maintain validation documentation (VMPs, URS, Functional Specs, Risk Assessments, IQ/OQ/PQ, Traceability).
• Collaborate with IT, QA, Development, and Business teams to define scope and strategies.
• Support audits/inspections with validation evidence.
• Perform periodic reviews and revalidations per change control or lifecycle stages.
• Provide CSV training and guidance to internal teams on compliance.
• Embed data integrity principles across systems and processes.
• Stay updated on evolving regulations and best practices.

Skills

Technical writing

Communication

Project management

Collaboration

Attention to detail

Education

Bachelor’s or Master’s in Computer Science/Life Sciences/Engineering

Tools

LIMS

ERP

eQMS

Cloud platforms (AWS/Azure)

Job description

About the Role:

We are seeking a seasoned Computer System Validation (CSV) and Regulatory Compliance Specialist with a strong background in GxP, GAMP 5, and 21 CFR Part 11 to lead and support the validation of our technology platforms, applications, and services. This individual will work closely with cross-functional teams to ensure that all systems impacting regulated data or processes are validated and maintained in accordance with applicable industry and regulatory standards.

Key Responsibilities:

• Lead and execute Computer System Validation (CSV) activities across various GxP-regulated systems and applications.
• Ensure all software, cloud platforms, and supporting infrastructure comply with GAMP 5 guidelines and 21 CFR Part 11 requirements.
• Develop and maintain validation documentation including:
  • Validation Plans (VMPs)
  • User Requirements Specifications (URS)
  • Functional Specifications
  • Risk Assessments
  • IQ/OQ/PQ Protocols and Reports
  • Traceability Matrices
• Collaborate with IT, Quality Assurance, Development, and Business teams to define validation scope and strategies.
• Support audits and inspections by providing evidence of validation and compliance.
• Perform periodic reviews and revalidations as required by change control or system lifecycle stages.
• Provide training and guidance to internal teams on CSV best practices and compliance requirements.
• Ensure data integrity principles are embedded across systems and processes.
• Maintain awareness of evolving regulations and best practices related to computerized system validation.

Required Qualifications:

• Minimum 10 years of experience in CSV within regulated industries (life sciences, healthcare, pharma, etc.)
• Deep understanding of GxP, GAMP 5, 21 CFR Part 11, and data integrity principles
• Demonstrated experience validating a variety of systems (e.g., LIMS, ERP, eQMS, cloud platforms, SaaS)
• Strong technical writing skills and attention to detail for documentation
• Experience supporting audits by FDA, EMA, or other regulatory bodies
• Ability to lead validation projects independently from planning through execution and closure
• Familiarity with change control, CAPA, and deviation management in regulated environments
• Excellent communication, collaboration, and project management skills

Preferred Qualifications:

• Certifications in CSV, GAMP 5, or related regulatory compliance programs
• Bachelor’s or Master’s degree in Computer Science, Life Sciences, Engineering, or related field
• Experience working in Agile/DevOps environments while ensuring compliance
• Familiarity with cloud platforms (e.g., AWS, Azure) and their validation in a regulated context