Quality Auditor / Inspector - M.A Professionals

Role Summary:
We are seeking a meticulous and experienced Quality Auditor / Inspector with a Master of Arts (M.A.) degree and 3-4 years of relevant experience to join our Quality Assurance team. The ideal candidate will be responsible for ensuring that clinical research activities conducted by Lambda Therapeutic Research Limited adhere to all applicable regulatory requirements, standard operating procedures (SOPs), and ethical guidelines. This role is crucial in maintaining the integrity and quality of our clinical trial operations.

Key Responsibilities:

- Conduct internal audits of clinical trial sites, data management processes, and other related activities to assess compliance with GCP, ICH guidelines, and internal SOPs.
- Review and evaluate study documentation, including protocols, case report forms (CRFs), and source documents, for accuracy, completeness, and adherence to regulatory standards.
- Identify deviations from established procedures and regulatory requirements, document findings, and recommend corrective and preventive actions (CAPA).
- Participate in external audits and inspections by regulatory authorities and clients.
- Monitor the implementation and effectiveness of CAPAs.
- Provide training and guidance to study teams on quality assurance principles and regulatory compliance.
- Stay updated with the latest regulatory guidelines and industry best practices.
- Prepare comprehensive audit reports and present findings to management.
- Contribute to the development and improvement of QA policies and procedures.