Technical Service Associate Manager

Process Validation & Product Life Cycle (PLC) management

• Coordinate validation team to prepare process validation protocol, report and execute Qualification and validation as per defined timeline.
• Implement new technology include project initiation and monitoring.
• Responsible to manage process validation life cycle across Abbott Site Cimanggis.
• Periodic review product quality aligns with Periodic Quality Report (PQR), and Continuous Process Verification (CPV) program.

Technical Problem Solving

• Data collection and investigation processes
• Post improvement monitoring
• Prepare documentation and conduct process optimization & validation
• Conduct sharing session/training to production team related to the solution
• Together with Technical Services Manager communicate to MS&T to escalate any cases could not be resolved locally.
• Act as site SME for Pharmaceutical Manufacturing Processes in relation to technical problem solving of new product or existing processes, includes but not limited to:

Product Transfer

Coordinate execution of product transfer & trial with others related department includes but not limited to:

• Prepare document related product transfer i.e., TT Plan, Validation and Engineering Study
• Launching product preparation
• Dossier preparation.
• Prepare time line related product transfer
• Coordinate with other department to execute the defined timeline

Cost Improvement

• Trial/Engineering/validation lot protocol preparation, execution and reporting
• Post validation monitoring
• Support and coordinate with related leader/supervisor on execution cost improvement program (new alternative supplier, process optimization, COMPETE program, etc.), include but not limited to :