CORE JOB TASK QA activities 1) Plan, schedule and perform internal, client and vender audits and reviews as required in order to assure that clinical studies managed by R&G PharmaStudies are of the highest standard and in compliance with the requirements of R&G PharmaStudies or Sponsor SOPs, study protocols and GxP. 2) Evaluate significance of audits findings and coordinate the findings responses with functional departments and/or study teams. 3) Manage processes for internal non-compliance corrective action plans. 4) Develop audit checklists, plans and agendas of audits for QA internal and external audits. 5) Assist in or host client audits and/or health authority inspections.
Training activities 1) Provide training to internal staff and/or investigational site staff on regulatory requirements, compliance standards, and quality initiatives in preparation of regulatory inspection. 2) Provide GCP compliance training, audit and inspection readiness training