● Prepare documentation of quality control as GMP required. (e.g. Specification, Test Procedure, Stability Protocol, Standard Operating Procedure, Test Report, and Certificate of Analysis)
● Check the action plan validation protocol to training and audit.
● Finalize the validation report and the qualification report. Notify the relevant agencies to approve the drug for sale.
● Prepare master list validation document.
● Follow up and report on actions qualification, validation, deviation report and change control in validation master plan.
● Prepare validation master plan schedule and validation summary report.
● Responsible for process inspection and audit plan on production process.
● Staff Training for QA, QC, and Production.
● Consumer complaint & Product recall Management.