Sr. QA Auditor

2 days ago


India Tilda Research Full time

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.



  • India Tilda Research Full time

    Remote: 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...


  • India Tilda Research Full time

    Remote: 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...


  • India Tilda Research Full time

    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...


  • India Tilda Research Full time

    Remote: 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...

  • Sr. QA Engineer

    5 days ago


    India Huptech HR Solutions Full time

    Job 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...

  • Sr. QA Engineer

    5 days ago


    India Huptech HR Solutions Full time

    Job 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...

  • Sr. QA Engineer

    2 days ago


    India Huptech HR Solutions Full time

    Job 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...

  • QA Automation

    3 weeks ago


    India Mount Talent Consulting Pvt Ltd. Full time

    Hi Folks, We are looking for QA Automation Engineer for one of the leading organization on the Payroll of Mount Talent Consulting. Please find below the Job Description: Sr. QA Automation 6+ years of professional experience in testing software, preferably in an Agile environment (Scrum, Kanban) Typescript, NodeJS, Playwright - mandatory. Java, Selenium -...

  • Internal Auditor

    3 weeks ago


    Kochi, Kerala, India, Ernakulam Cyrix Healthcare Private Limited Full time

    We are looking for an Internal Auditor (CA Inter) with strong knowledge of internal controls, compliance, and process reviews.Experience Required: CA Inter + 3 years Articleship + 2 years Internal Audit experienceKey Responsibilities:Review and test internal controls across Finance, Procurement, HR, Operations, Sales, Inventory & IT.Perform compliance checks...


  • India K3-Innovations, Inc. Full time

    Job Title: Clinical Quality Compliance ManagerLocation: Bengaluru, Karnataka, IndiaReports To: QA/Compliance Director or Clinical Operations DirectorJob Summary:Clinical Site Auditor to ensure compliance and quality at Clinical Trial sites. You will conduct site audits, review documentation, and verify adherence to protocols, GCP, GLP and regulatory...