Validation Specialist
Cikarang
1. Prepare monthly Qualification schedule and report2. Make protocol, execution, and report for machine/system/instrument Qualification. Qualification and re-Qualification (sterile / non sterile), such as lyophilization machine, autoclave, mixing tank, dry powder filling, liquid, and tabletting3. Make protocol, execution, and report for Gowning Validation4. Make protocol, execution, and report for Media Fill, including make risk assessment5. Successful doing FAT and SAT with… Show more 1. Prepare monthly Qualification schedule and report2. Make protocol, execution, and report for machine/system/instrument Qualification. Qualification and re-Qualification (sterile / non sterile), such as lyophilization machine, autoclave, mixing tank, dry powder filling, liquid, and tabletting3. Make protocol, execution, and report for Gowning Validation4. Make protocol, execution, and report for Media Fill, including make risk assessment5. Successful doing FAT and SAT with foreign technicians6. Join team for water and HVAC qualification7. Supporting audit by international regulatory and local regulatory Show less