Senior QA Auditor/ Senior GCP Auditor
4 weeks ago
Remote: IndiaOpen to candidates with experience in global clinical research operations.About the RoleWe are seeking a Senior QA Auditor/ Senior GCP Auditor professional with proven experience in audits, SOP management, and regulatory compliance across global clinical research environments. This role is ideal for someone who has worked within or closely with a global CRO, understands the complexities of multi-country trial oversight, and can ensure all operations meet FDA, ICH-GCP, and 21 CFR Part 11 standards.The successful candidate will serve as a key liaison between QA, Clinical Operations, and Regulatory Affairs—driving quality excellence, maintaining inspection readiness, and strengthening our Quality Management System (QMS) across all programs.Key Responsibilities- Lead and execute internal, external, vendor, and investigator site audits to ensure compliance with GCP and regulatory standards. - Establish, maintain, and continuously improve the Quality Management System (QMS) across global studies and vendors. - Serve as SOP owner for QA and compliance documentation—authoring, revising, and harmonizing procedures across business units. - Manage SOP lifecycle processes, including creation, periodic review, deviation tracking, version control, and global rollout. - Support regulatory inspection readiness (FDA, MHRA, EMA, DCGI, etc.) and act as QA representative during inspections. - Lead CAPA investigations, ensuring timely and effective root cause analysis, remediation, and verification of effectiveness. - Collaborate cross-functionally with Clinical Operations, Data Management, Biostatistics, and Regulatory teams to ensure compliance across all study phases. - Provide compliance training and guidance to internal and external stakeholders, promoting a strong culture of quality and accountability. - Monitor and interpret evolving global regulatory requirements, ensuring timely updates to SOPs and operational processes. - Oversee vendor qualification, risk assessments, and QA oversight for global partners, CROs, and laboratories.Qualifications- Bachelor’s or advanced degree in Life Sciences, Quality Assurance, Regulatory Affairs, or related field. - Experience with CSV ( Computer System Validation ) Audits - 5–10 years of experience in Quality Assurance or Compliance roles within the clinical research industry, including experience with a CRO, pharma, or biotech organization. - Deep understanding of FDA, ICH-GCP, HIPAA, and 21 CFR Parts 11, 50, 54, 56, 312, and 812. - Proven success managing audits, inspections, and SOP systems across global clinical programs. - Demonstrated ability to implement and maintain a robust QMS and drive continuous improvement initiatives. - Strong communication and collaboration skills with the ability to influence cross-functional stakeholders. - Certifications such as ASQ CQA, RAC, or SOCRA/ACRP QA credentials are a plus.Preferred Attributes- Prior experience supporting multi-region clinical programs and global quality frameworks. - Exceptional attention to detail, documentation discipline, and process ownership. - Ability to translate regulatory standards into practical operational guidance. - - Comfortable leading in a fast-paced, inspection-ready, and globally distributed environment.
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Senior QA Auditor/ Senior GCP Auditor
4 weeks ago
Delhi, India Tilda Research Full timeRemote: IndiaOpen to candidates with experience in global clinical research operations.About the RoleWe are seeking a Senior QA Auditor/ Senior GCP Auditor professional with proven experience in audits, SOP management, and regulatory compliance across global clinical research environments. This role is ideal for someone who has worked within or closely with...
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Senior QA Auditor/ Senior GCP Auditor
6 days ago
Delhi, India Tilda Research Full timeRemote: IndiaOpen to candidates with experience in global clinical research operations.About the RoleWe are seeking a Senior QA Auditor/ Senior GCP Auditor professional with proven experience in audits, SOP management, and regulatory compliance across global clinical research environments. This role is ideal for someone who has worked within or closely with...
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Senior Auditor
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New Delhi, India Xret Analytics Private Limited Full timeCompany Description Xret Analytics Private Limited is a knowledge process outsourcing company based in Kochi. We provide back-office support to one of the leading CA firms in the UAE. We seek CA /ACCA members or semi-qualified CAs with at least one year of experience in a medium-sized CA firm.Role Description This is a full-time, on-site Senior Auditor role...
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Delhi, Delhi, India ReliefWeb Full time ₹ 4,00,000 - ₹ 8,00,000 per yearIndiaSenior AuditorOrganizationInternational Federation of Red Cross and Red Crescent SocietiesPosted 12 Nov 2025 Closing date 17 Nov 2025Organizational ContextThe International Federation of Red Cross and Red Crescent Societies (IFRC) is the world's largest humanitarian network, with 191-member National Societies. IFRC is part of the International Red Cross...
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Auditor
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Delhi, Delhi, India International Federation of Red Cross and Red Crescent Societies - IFRC Full time ₹ 4,00,000 - ₹ 8,00,000 per yearOrganizational ContextThe International Federation of Red Cross and Red Crescent Societies (IFRC) is the world's largest humanitarian network, with 191-member National Societies. IFRC is part of the International Red Cross and Red Crescent Movement, together with its member National Societies and the International Committee of the Red Cross (ICRC).IFRC works...
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Auditor
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Delhi, Delhi, India International Federation of Red Cross and Red Crescent Societies Full time ₹ 4,00,000 - ₹ 8,00,000 per yearVacancy No.S15815Category of ContractNationalPosition TypeNationalApplication Deadline11/11/2025Job Posted On27/10/2025Duty StationNew Delhi, IndiaDuration12Organizational ContextThe International Federation of Red Cross and Red Crescent Societies (IFRC) is the world's largest humanitarian network, with 191-member National Societies. IFRC is part of the...
