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