Sr. QA Auditor
3 days ago
Remote: India Open to candidates with experience in global clinical research operations. We 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. 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. 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. 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. ~ 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. ~ Certifications such as ASQ CQA, RAC, or SOCRA/ACRP QA credentials are a plus. Prior experience supporting multi-region clinical programs and global quality frameworks. 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
India Tilda Research Full timeRemote: India Open to candidates with experience in global clinical research operations. About the Role We 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...
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Senior QA Auditor/ Senior GCP Auditor
4 weeks ago
India Tilda Research Full timeRemote: India Open to candidates with experience in global clinical research operations. About the Role We 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...
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Senior QA Auditor/ Senior GCP Auditor
4 weeks ago
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
3 days ago
India Tilda Research Full timeRemote: India Open to candidates with experience in global clinical research operations. About the Role We 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...
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MAIORA - QA AUDITOR
6 days ago
india Nexthire Full timeJob Title Q A Auditor Total Experience: 1 – 2 Years Location: Remote Notice Period: Immediate – Serving NP within 15 days Budget 9 LPA Job Description: Responsibilities will include: Supporting the Internal Audit Advisory Committee by: Scheduling meetings Preparing agendas and agenda items Capturing and tracking actions and decisions Supporting the...
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Pharmacovigilance QA Auditor
6 days ago
Gurugram, India SUN PHARMA Full timeJob Description Title Pharmacovigilance QA Auditor Business Unit R&D Quality Job Grade Executive / G12A Location: Gurugram, H.R. Key Responsibilities At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to...
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Pharmacovigilance QA Auditor
2 weeks ago
India Sun Pharmaceutical Industries - Full time ₹ 45,00,000 - ₹ 55,00,000 per yearTitle:Pharmacovigilance QA Auditor Business Unit:R&D QualityJob GradeExecutive / G12ALocation:Gurugram, H.R.Key ResponsibilitiesAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own...
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Sr. QA Engineer
4 weeks ago
India Huptech HR Solutions Full timeJob Post Sr. QA Engineer (Automation + Manual)Experience: 5 to 10 Years Location: Remote (Indian Candidate Only)Responsibilities:The Quality Assurance Engineer will be responsible for ensuring the product quality through the planning and execution of product testing, and/or process/product standards complianceThe position demands direct involvement in manual...
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Sr. QA Engineer
4 weeks ago
India Huptech HR Solutions Full timeJob Post Sr. QA Engineer (Automation + Manual) Experience: 5 to 10 Years Location: Remote (Indian Candidate Only) Responsibilities: The Quality Assurance Engineer will be responsible for ensuring the product quality through the planning and execution of product testing, and/or process/product standards compliance The position demands direct involvement in...
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Immediate Start! KPO QA
2 weeks ago
India Virtusa Full timeJob Description Sr. Quality Analyst Role Objective The Senior Quality Analyst is responsible for ensuring the accuracy, compliance, and quality of order forms and contracts processed under Googles Deal Operations workflows. The role involves performing detailed audits, identifying process gaps, driving root cause analysis (RCA), and collaborating with...
