QA/QC Manager - PT. JAYA SWARASA AGUNG, Tbk. - Tangerang
(2019-08)
- Prepare document: Quality Plan, QC Work Instructions, Check Sheet, Analytical Procedure, Calibration & SOP
- Ensuring from release process to be done on time for RM, PM, WIP and FG
- Review team structure & roles and ensure covering lab scope and develop succession plan
- Provide training (ISO 22000: 2018, FSSC 22000, GMP, HACCP, SJ Halal MUI, Line Clearance, Product Knowledge, Sampling Method, SMK3, Calibration, etc.) for Factory Employee
- Review training needs for lab staff based on training plan & training Records and to cover Personal skill gabs
- Evaluate analytical result (water treatment & waste water treatment, incoming materials, packaging material, microbiology, in-process & product, and stability sample), validation report
- Monitor the results of the retained sample test periodically
- Monthly review for lab budget and measure performance vs targets
- Participate and lead Factory employee to participate on ISO 22000: 2018, SNI 2973: 2022, CPPOB & SJ Halal MUI
- Schedule planning and conduct external and internal audits referring to GMP, CPPOB, SJ Halal, SNI and ISO 22000 standards
- Conduct, participate and follow up external & Internal Quality Audit with suppliers and issuing audit report and identifying non-compliance cases to ensure that corrective action are implemented
- Following up customer complaints in order to trace the main problems that lower the quality of the produced and find the radical solution for the problem
QC/QA Manager - PT. LECAPSEAL INDONESIA - Bekasi
(2012-11 - 2018-07)
- Prepare document: QC Work Instructions, Check Sheet, Analytical Procedure, Calibration & SOP
- Ensuring from release process to be done on time for RM, PM, WIP and FG
- Review team structure & roles and ensure covering lab scope and develop succession plan
- Provide training (ISO 9000, ISO 22000, FSSC 22000, BRC IoP, GMP, HACCP, SJ Halal MUI, Line Clearance, Product Knowledge, Sampling Method, SMK3, Calibration, etc.) for Factory Employee
- Review training needs for lab staff based on training plan & training Records and to cover Personal skill gabs
- Evaluate analytical result (water, incoming materials, packaging material, in-process & product, and stability sample), validation report
- Monthly review for lab budget and measure performance vs targets
- Participate and lead Factory employee to participate on ISO 9000, FSSC 22000 & SJ Halal MUI
- Schedule planning and conduct external and internal audits referring to GMP, SJ Halal and FSSC 22000 standards
- Conduct, participate and follow up external & Internal Quality Audit with suppliers and issuing audit report and identifying non-compliance cases to ensure that corrective action are implemented
- Provide recommendations for improvements to the building / layout and factory production processes according to GMP & ISO 22000 standards
- Following up customer complaints in order to trace the main problems that lower the quality of the produced and find the radical solution for the problem
Quality Control & Product Development Manager - PT. ORSON INDONESIA - Jakarta
(2010-01 - 2011-07)
- Manage QC & Product Development department activities
- Research & Development for new formulation & packaging based on NPL (New Product Launching) Project from marketing
- Prepare document: Standard Operating Procedure, Raw Material Specification, Analytical Procedure, Method Validation Protocol, Working Instruction
- Provide training (GMP, ISO 9000, Analytical Procedure, Method Validation Procedure, Audit, Manual Instruction, etc.) for Factory Employee
- Coordinate with design department, marketing and production department in new product development
- Approved new product development permit & packaging replacement to BPOM
- Develop analytical procedure
- Supervise activity of QC personnel
- Evaluate analytical result (water, incoming materials, packaging material, in-process & product, and stability sample), validation report
- Give approval of raw material, packaging material, in-process product, stability sample & validation
- Schedule planning and conduct external and internal audits referring to GMP, and ISO 9000 standards
- Make communication with supplier
- Count man hours of analyst and utilization of laboratory instrument
- Plan supplying QC reagent & equipment/instrument
- Arrange QC & Product Development department budget
Quality Control Supervisor and QMR (Quality Management Representative) - PT. UNZA VITALIS (WIPRO Group) - Jakarta & Salatiga
(2004-08 - 2009-12)
- Prepare document: Standard Operating Procedure, Raw Material Specification, Analytical Procedure (Chemical, Physical & Microbiology), Calibration Procedure, Validation Protocol, Working Instruction
- Training analyst in GMP, ISO 9000, SJ Halal, Analytical Procedure, Calibration Procedure, Manual Instruction
- Ensure that the manufacturing products meets the requirement of GMP, SJ Halal MUI & ISO 9000
- Develop analytical procedure & Supervise activity of analyst in Laboratory
- Prepare vendor audit program including third party manufacturing audit
- Evaluate analytical result (raw materials, water, waste water)
