▷ [Immediate Start] CSV & Regulatory Compliance Specialist
5 days ago
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
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CSV & Regulatory Compliance Specialist
1 week ago
Pune, Maharashtra, India TransPerfect Full time ₹ 20,00,000 - ₹ 25,00,000 per yearAbout 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...
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Pune, Maharashtra, India TransPerfect Full time ₹ 15,00,000 - ₹ 25,00,000 per yearAbout 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...
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CSV Specialist
1 week ago
Ahmedabad, Gujarat, India, Gujarat Adrta Technologies Private Limited Full timeJob Summary:We are seeking a skilled and detail-oriented CSV Specialist to join our team. In this role, you will be responsible for developing, executing, and maintaining validation protocols and documentation to ensure compliance with regulatory standards. The ideal candidate will collaborate with cross-functional teams, contribute to audits and...
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▷ 3 Days Left! GxP Validation
4 weeks ago
Bengaluru, India Prana Tree Full timeJob Description Job Description GxP Validation & Compliance Specialist (Contract) Position Type: Contract (6 Months) Open Positions: 01 Location: Bangalore (Preferred) Experience Required: 46 years Role OverviewWe are looking for a skilled GxP Validation & Compliance Specialist to ensure that all digital twin workflows comply with global regulatory...
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Cyber-CSV
3 weeks ago
Pune, India Talent Worx Full timeWe’re hiring for one of the world’s leading professional services firms, renowned for its commitment to innovation, excellence, and global impact. With a presence in over 150 countries, this organization provides services across consulting, audit, tax, risk advisory, and financial advisory — helping Fortune 500 companies and governments navigate...
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Cyber-CSV
3 weeks ago
Pune, India Talent Worx Full timeWe’re hiring for one of the world’s leading professional services firms, renowned for its commitment to innovation, excellence, and global impact. With a presence in over 150 countries, this organization provides services across consulting, audit, tax, risk advisory, and financial advisory — helping Fortune 500 companies and governments navigate...
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Cyber-CSV
1 week ago
Pune, Maharashtra, India Talent Worx Full time ₹ 5,00,000 - ₹ 25,00,000 per yearWe're hiring for one of the world's leading professional services firms, renowned for its commitment to innovation, excellence, and global impact. With a presence in over 150 countries, this organization provides services across consulting, audit, tax, risk advisory, and financial advisory — helping Fortune 500 companies and governments navigate complex...
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Cyber-CSV
4 days ago
Pune, Maharashtra, India Talent Worx Full time ₹ 12,00,000 - ₹ 36,00,000 per yearWe're hiring for one of the world's leading professional services firms, renowned for its commitment to innovation, excellence, and global impact. With a presence in over 150 countries, this organization provides services across consulting, audit, tax, risk advisory, and financial advisory — helping Fortune 500 companies and governments navigate complex...
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Regulatory Compliance Specialist
3 weeks ago
India Jupiter AI Labs ✔ Full timeAbout the Role: We are seeking a Regulatory & Compliance Specialist on a contract basis to support our compliance requirements in India and international destination countries. This role is ideal for professionals experienced in handling regulatory filings, certifications, and export-related compliance in pharma, Ayurveda, nutraceuticals, or cosmetics. Key...
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Regulatory Compliance Specialist
4 weeks ago
India Jupiter AI Labs ✔ Full timeAbout the Role:We are seeking a Regulatory & Compliance Specialist on a contract basis to support our compliance requirements in India and international destination countries. This role is ideal for professionals experienced in handling regulatory filings, certifications, and export-related compliance in pharma, Ayurveda, nutraceuticals, or cosmetics.Key...
