Quality Assurance Compliance Specialist

5 days ago


rajahmundry, India beBeeClinicalResearchAuditor Full time

Job OverviewWe are seeking an experienced Clinical Research Auditor to join our team. The successful candidate will be responsible for conducting thorough site audits, reviewing documentation, and verifying adherence to protocols, GCP, GLP, and regulatory requirements.Main Responsibilities:Audit clinical research sites across phases I–IV, ensuring compliance with established standards.Review CRFs, informed consent forms, and regulatory documents to identify any discrepancies or areas for improvement.Identify and report audit findings, recommending corrective actions to ensure quality and compliance.Support site staff with guidance on compliance and training, promoting a culture of excellence.Prepare detailed audit reports, tracking progress and follow-up on CAPA implementation.Requirements:Bachelor's degree in life sciences, nursing, pharmacy, or a related field, demonstrating a strong foundation in the subject matter.No less than 10-12 years of clinical research experience, with a proven track record in auditing and QA.Demonstrated knowledge of GCP, ICH guidelines, and FDA/EMA regulations, as well as excellent analytical, communication, and organizational skills.Ability to travel is required, with a valid passport and willingness to work in diverse environments.About this Opportunity:This role offers a unique chance to make a meaningful impact in the pharmaceutical industry, working closely with cross-functional teams to drive quality and compliance.What We Offer:A competitive compensation package, comprehensive benefits, and opportunities for professional growth and development.



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