Wijaya Wisnu Putra

• Actively coordinating with teams to ensure project (i.e. laboratory equipment qualification, etc.) in QC Laboratory are delivered in most effective way and meet target dates.
• Maintain and ensure compliance in Quality and Safety such as submitting CAPA as per committed in QC Laboratory.
• Leading and coordinating qualification of laboratory instrument.
• Review computerized system validation result in QC Laboratory.
• Perform periodic review related to audit trail, user privilege, back-up, restore and data integrity gap assessment for instrument and QC documents.
• Hold and maintain administrator account in equipment and instrument in QC Laboratory.
• Maintain QC Laboratory documentation and doing Laboratory investigation, Manufacturing investigation and closure of all commitments.
• Managing calibration activities in QC Laboratory and review calibration/verification report.
• Develop and implement Laboratory Information Management System.

• Performed routine testing using HPLC, GC, AAS, UV-Vis Spectrophotometer, IR Spectrophotometer.
• Performed equipment qualification.
• Generated trending data.
• Performed packaging material sampling and testing.
• Performed analytical method validation.

• Performed routine testing (Sterility Testing, Bacterial Endotoxin Testing, Environmental Monitoring Sampling, Microbial Identification, and Microbial Limit Test).
• Performed validation and verification of analytical method.
• Performed equipment qualification (Biological Safety Cabinet, Incubator, Isolator).
• Generated trending data.

Training at Indonesia International Institute for Life Sciences (i3L). BTP is tailored program designed to cultivate advanced skills and knowledge related to biotechnology, biomanufacturing and pharmaceutical industries.