Technical Service Associate Manager

**Process Validation & Product Life Cycle (PLC) management**
- Responsible to manage process validation life cycle across Abbott Site Cimanggis.
- 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.
- Periodic review product quality aligns with Periodic Quality Report (PQR), and Continuous Process Verification (CPV) program.

**Technical Problem Solving**
- 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:

- Data collection and investigation processes
- Together with Technical Services Manager communicate to MS&T to escalate any cases could not be resolved locally.
- Prepare documentation and conduct process optimization & validation
- Conduct sharing session/training to production team related to the solution
- Post improvement monitoring

**Product Transfer**

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

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

**Cost Improvement**
- 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:

- Trial/Engineering/validation lot protocol preparation, execution and reporting
- Post validation monitoring