Experience

Pharma Metric Labs

• Indonesia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory & Data Management Department Head

  • Mar 2020 - Present

  Development of clinical study protocol and clinical study report (CSR) for bioequivalence (BE) study. Ethics review submission for initial and amendment study, serious adverse event (SAE) reporting, and close out study. Communicate with BPOM regarding to study approval and the CSR evaluation. Randomization of the investigational product (IP).

• Responsible Pharmacist and Data Management Officer

  • Apr 2013 - Feb 2020

  Development of clinical study protocol and clinical study report (CSR) for bioequivalence (BE) study. Ethics review submission for initial and amendment study, serious adverse event (SAE) reporting, and close out study. Communicate with BPOM regarding to study approval and the CSR evaluation. Randomization of the investigational product (IP). Pharmacokinetics and statistical analysis for BE study manually by Ms Excel or by WinNonlin and EquivTest software. Managing the investigational product (IP) storage. Show less

• Quality Assurance Officer

  • Mar 2012 - Mar 2013

  Ensure the implementation of ISO 17025 in laboratory and GCP regading to bioequvalence studyPerform audit process of bioequivalence study



SOHO Global Health

• Indonesia
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Physical Chemical - Inspection Section Head & Quality Compliance Executive

  • Oct 2010 - Mar 2012

  Supervise the testing of incoming raw and packaging material. Coordinate all activities of the product's follow up stability. Supervise the testing of incoming raw and packaging material. Coordinate all activities of the product's follow up stability.



PT Metiska Farma

• QA Staff

  • Jun 2009 - Sep 2010

  Analytical method validation execution Process validation coordination Annual product review coordination Analytical method validation execution Process validation coordination Annual product review coordination