CSV & Regulatory Compliance Specialist | Pune

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

• Bachelors or Masters 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