Job Summary

• Conduct real time investigation on site of event, deviation, and other non-conformance to ensure that proper investigation is performed to address the issue
• Supervise real time in critical production process and in-process control (IPC) activities to ensure activities are conducted in compliance with applicable procedure
• Perform batch documentation review during process or after process on site to ensure that all products are manufactured in accordance with cGMP and registration dossier
• Provide real time quality impact assessment of any nonconformance/issue which has potential impact to product quality
• Perform CAPA Effectiveness check on site
• Conduct Quality Management System Gap analysis for topic related to Quality Assurance
• Demonstrate and lead by example for the implementation of Good Documentation Practice
• Conduct regular oversight with proper evidence

Requirements

• Have min. Bachelor Degree in Biotechnology, Biology, Chemistry. Preferably Pharmacy.
• Have min. 1 year of experience in the Pharmaceutical Industry; fresh graduates are welcome.
• Have good understanding in GMP
• Excellent skills in prioritizing and time management
• Fluent in English (both written and spoken)
• Able to work independently (self-motivated) and within a complex team environment
• Willing to be stationed in East-Jakarta
• Willing to work with limited resources in a Start-Up Environment
• Willing to work in shifts
• Willing to work with overtime if needed