Eko Setiyo Hadi

1. Create and set up a document control system.

2. Review and approve the quality manual, standard operational procedure, and work instruction.

3. Set up the 5R Standard, establish the 5R system, and audit.

4. Coordinating all activities in the QA and QC area.

5. Involve in deviation investigation.

6. Coordinating implementation of change management system.

7. Develop and set up a company risk register system.

8. Develop and set up a serialization barcode system.

9. Established computerized system validation.

10. Continuous Improvement Program Initiator and Facilitator.

11. Set up and maintain Halal Assurance System

12. Set up and maintain HSE System including ISO 14001 & 45001

1. Registered Quality Assurance Pharmacist.

2. Managing deviation and investigation during all stage of production and giving final disposition.

3. Evaluating the batch record for product-releasing activity.

4. Developing Quality system and improvement to achieve compliance towards cGMP (CPOB).

5. Managing all activity related to enforcement of process validation, cleaning validation, machine and utility qualification and calibration of measurement equipment.

6. Managing all activity related to document control system, record and database management

7. Establishing product quality review using six-pack capability analysis (MINITAB®) and trend analysis to support consistency of process and quality.

8. Managing all activity related to audit (internal and external) to assure all aspect of cGMP (CPOB) consistently implemented.

9. Managing all activity related with fulfillment of CAPA.

10.Coordinating Pharmacovigilance implementation such as reporting and monitoring adverse drugs reaction happened during post marketing activity.

11.Developing Quality Risk Management using FMEA (Failure Mode Effect Analysis).

12.Managing and coordinating new and existing production facility cGMP certification and/or recertification.

1. Controlling production process to achieve monthly production target.

2. Coordinating manpower to support production process.

3. Controlling GMP implementation in production area.

4. Making weekly production schedule based on weekly production plan.

5. Budgeting and cost expense planning and controlling.

6. Coordinating toward related department to ensure production process will be running well (PPIC, warehouse, QC, QA, etc)

7. Reporting production achievement such as productivity, Efficiency, Direct Labor Cost, Factory Overhead Cost, Cost Saving, etc

8. Arranging CAPA needed for all management system inspection finding such as Quality internal audit, ISO 9001:2008 audit, Regulatory audit, etc.

9. Project assistant for developing and designing process modification to achieve better productivity, conceptualize automation packaging system with vendor and engineering team, involved in developing and designing water treatment system and air handling system installation and commissioning.

1. Evaluating Production Batch Record for product releasing activity.

2. Preparing Annual Product Quality Review (PQR) to analyze product quality using statistical tool such as MINITAB®.

3. Handling supervision for process inspection activity to assure that all aspects of production process meets all GMP requirements and produce high quality products with minimal defect.

4. Investigating customer complaint to find the root cause of quality defects and set up the CAPA (Corrective Action Preventive Action) in order to increase improvements in all of aspect for prevent quality defect in the future.

5. Investigating all deviation happened during all stage of production process and set up the CAPA.

6. Handling calibration program to ensure all of measurement equipment well calibrated.

7. Handling qualification activity toward all machine, equipment and utility to prove the reliability.

8. Coordinating GMP internal training for QA/QC personnel.

9. Reviewing and developing quality system procedure for internal QA/QC department to comply all aspect of GMP, ISO 9001 and all management system applied in PT. Bintang Toedjoe.

10. Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) of thermoforming filling machine in Modena, Italia.