Senior QA Auditor/ Senior GCP Auditor

4 weeks ago

Nadiad, India Tilda Research Full time

Remote: India Open to candidates with experience in global clinical research operations. About the Role We are seeking aSenior QA Auditor/ Senior GCP Auditorprofessional 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.

  • Senior QA

    7 days ago

    nadiad, India CES Full time

    We are looking for a highly skilled and detail-oriented Senior QA Engineer to help elevate the quality, performance, and accessibility of our web applications. In this role, you will work closely with cross-functional teams, lead test automation initiatives, and ensure our products meet the highest standards of reliability and user experience.What You'll...

  • Senior Associate

    2 weeks ago

    Nadiad, India Terracegate Full time

    Role Summary:We are seeking an experienced Financial Controller / Accounting Specialist to work with one of our clients. The role involves managing day-to-day accounting operations, inter-company reconciliations, multi-entity reporting, and financial dashboards. The ideal candidate will be hands-on with accounting and reporting, comfortable working...

  • Senior datacenter network engineer(aviatrix)

    6 days ago

    Nadiad, India H3 Technologies, LLC Full time

    Role : Network Engineer IV Experience: 10+ Years Location : Chennai preferable (Remote options for other location). Shift : Rotational Senior Datacenter Network Engineer (Level 4) Job Description: Senior Datacenter Network Engineer (Level 4) with extensive expertise in designing and managing sophisticated network infrastructures within large-scale...

  • Senior Java Architect

    2 weeks ago

    Nadiad, India HGS Full time

    Job Title: Senior Java Architect / SME – Banking Domain Experience: 12+ yearsRole:We are looking for an experienced Senior Java Architect (SME level) with deep expertise in enterprise application architecture and proven experience in the Banking and Financial Services domain. The ideal candidate will define and drive the technology architecture, ensure...

  • Senior Scientist

    2 weeks ago

    Nadiad, India KRISHGEN BIOSYSTEMS PRIVATE LIMITED Full time

    Company DescriptionKRISHGEN is a leading ELISA kit manufacturer with plant in Bhiwandi, Thane. We manufacture assays for cytokines, therapeutic drugs and other pathways. This position is for Bhiwandi, Thane, Maharashtra state.Role DescriptionThis is a full-time remote role for a Senior Scientist at KRISHGEN BIOSYSTEMS PRIVATE LIMITED. The Senior Scientist...

  • Senior Frontend Developer

    2 weeks ago

    Nadiad, India Intelliveer Full time

    Company Description Intelliveer is a healthcare company building e2e PMS software for orthodontist. Role Description This is a full-time remote role for a Senior Frontend Developer. The Senior Frontend Developer will be responsible for designing and implementing complex web applications and features, ensuring overall performance, usability, and reliability....

  • Elevating Quality Through Expert Test Engineering

    7 days ago

    nadiad, India beBeeQuality Full time

    Senior QA EngineerWe are seeking a highly skilled Senior QA Engineer to elevate the quality and performance of our web applications. In this role, you will lead test automation initiatives and ensure our products meet the highest standards of reliability and user experience.Cypress Automation Frameworks: Design and maintain UI automation frameworks using...

  • Senior quality assurance engineer

    1 week ago

    Nadiad, India PureSpectrum Full time

    Who We Are: Pure Spectrum is a rapidly growing market research and insights platform. We simplify technology for researchers so they can gather and use consumer data the way they want – without disruption. Pure Spectrum currently facilitates more than 65 million online interviews annually through our Marketplace. Pure Spectrum also developed the...

  • Senior manager international tax

    6 days ago

    Nadiad, India RSM US LLP Full time

    RSM’s International Tax Business practice is a national capability that focuses on serving US and Foreign multi-national business’s US international tax advisory and compliance needs in coordination with foreign tax advisors and applicable laws. This includes advising businesses on the application of US and foreign tax law to a business and how that...

  • Manual testing with OBDX- Onsite Oman

    4 days ago

    Nadiad, India Betterbeans Consultants Pvt Ltd Full time

    Seeking a Senior Test Engineer with strong expertise in OBDX and OBPM Corporate and Transaction Banking processes , including Virtual Account Management, Cash and Liquidity Management, Trade and Supply Chain Finance, Corporate Limits and Collaterals, Corporate Finance, and Host-to-Host connectivity . The ideal candidate should have a deep understanding of...