Harianto Apt.
Cikarang,West Java
Summary
Quality assurance professional with history of ensuring high standards and consistent results in production environments. Proven ability to drive quality improvements and maintain compliance with industry standards. Known for effective team collaboration and adaptability to changing requirements, ensuring reliable outcomes. Skilled in root cause analysis and process optimization.
Overview
7
7
years of professional experience
Work History
Quality Assurance Supervisor
PT. Supra Ferbindo Farma (The Tempo Group)
Cikarang, West Java
02.2019 - Current
- Carry out training to all employees on aspects of Good Manufacturing Practices (GMP) for drugs.
- Conduct performance qualifications on critical support facilities including air handling units, water treatment systems and compressed air.
- Conduct validations including Cleaning Validation, Temperature Mapping Validation, Process Validation and Analytical Method Validation for Cleaning Validation.
- Reviewing and handling nonconformities that occur in the production line and Change Management related to product quality.
- Conduct transportation verification for finished goods including creating protocols, carrying out transportation verification and creating reports.
- Carry out inspections and handling of return products.
- Conduct investigations and develop preventive action plans to resolve product complaints.
- Conduct investigations and prepare product recall reports.
- Conduct annual self-inspections and quality audits of all sections to ensure compliance with Good Manufacturing Practices (GMP).
- Prepare annual vendor evaluation reports and conduct vendor audits on selected vendors.
- Control, compile and review Corrective Action (CA) and Preventive Action (PA) from internal audits and external audits.
- Carry out periodic monitoring of clean room in production area includes temperature, humidity, differential pressure, air change, microbiology and particle count.
- Prepare annual Product Quality Review (PQR) for all products manufactured.
- Monitoring stability chamber, preparing stability protocols, preparing stability sample inspection schedules, reviewing reports on stability sample test results and preparing annual stability evaluation reports.
- Reviewing, preparing and archiving all required standard operating procedures.
- Batch Record handling includes reviewing and archiving Batch Records.
- Compile, monitor and control retained sample of each product.
- Conduct a comprehensive batch evaluation of the entire production process and release the finished product.
- Create and review quality risk management on all aspects of Good Manufacturing Practices (GMP).
Quality Assurance Supervisor and Quality Pharmacist
PT. Tempo Merah Putih (The Tempo Group)
Cikarang, West Java
02.2021 - 06.2023
- Carry out training to all employees on aspects of Good Manufacturing Practices (GMP) for medical devices.
- Conduct performance qualifications on all machines and equipment used in production line including creating protocols, carrying out performance qualifications and creating reports.
- Validating the production process including creating protocols, carrying out validation and creating reports.
- Conduct annual self-inspections and quality audits of all sections to ensure compliance with Good Manufacturing Practices (GMP).
- Carry out inspection of raw materials, inspection of bulk products and finished products in accordance with the specified parameters.
Foreman In Process Control Quality Assurance
PT. Tempo Natural Products (The Tempo Group)
Cikarang, West Java
09.2018 - 01.2019
- Carry out In Process Control on the mixing process such as suitability of raw materials, suitability of weighing results of raw materials, correctness of the mixing process sequence and suitability of process parameters.
- Carry out In Process Control on primary and secondary packaging processes such as volume compliance, torque, leak tests, packaging correctness and coding correctness.
- Conduct sampling of mixing process and testing during in-process control such as volume compliance, torque, leak tests.
- Investigate any nonconformities that occur in the production line including reviewing, preparing and storing nonconformities documents.
- Validating the production process including creating protocols, carrying out validation and creating reports.
Production Officer
PT. Dexa Laboratories of Biomolecular Science
Cikarang, West Java
03.2018 - 09.2018
- Manage man power to carry out the production process according to the production schedule.
- Ensure production process runs according to established procedures and standards.
- Prepare weekly production schedules.
- Provide training to production operators.
- Analyze production problems and develop action plans to resolve them.
- Investigate any nonconformities that occur in the production line.
- Prepare production report and document, including reviewing, preparing and storing production records and periodic production reports.
- Create and update standard operating procedures in the production department according to established procedures and standards.
- Coordinate with related departments to support production processes.
Skills
Validation protocols
Auditing techniques
Supplier quality management
Customer complaint handling
Problem-solving skills
Quality management systems
Risk management
Data analysis
Documentation control
Timeline
Quality Assurance Supervisor and Quality Pharmacist
PT. Tempo Merah Putih (The Tempo Group)
02.2021 - 06.2023
Quality Assurance Supervisor
PT. Supra Ferbindo Farma (The Tempo Group)
02.2019 - Current
Foreman In Process Control Quality Assurance
PT. Tempo Natural Products (The Tempo Group)
09.2018 - 01.2019
Production Officer
PT. Dexa Laboratories of Biomolecular Science
03.2018 - 09.2018