JOBSCOPE OVERVIEW
1. Represent QA/QC department in 2G Management Meetings or other meetings required by Directors.
2. Create and maintain standard operating procedure (SOP’s), protocols, guidelines that ensure consistency and efficiency throughout the QA cycle.
3. Acts as Committee of all ISO audits.
4. Supervise and manage QA/QC team and interns.
5. Conduct physico-chemical and microbiological test for Chemicals and Incoming Paper.
6. Liaise with suppliers and third-party agencies.
7. Provide technical support to the sales and marketing team regarding product specifications, sample requirement & others.
8. Document those methods in standard operating procedures (SOPs) and production records, quality assurance activities with internal reporting and audits.
9. Review and compile documents for Audits (Batch Record: Prod sheet, Quality control test Reports; FG and RM Reports, Mixing records).
10. Ensure that on time calibration program of equipment (mechanical and lab instruments, weighing scales and test weights) are executed.
11. Assist to do in compounding and mixing when Mixer Operator is on leave.
12. Liaise with Overseas factory (China and Indonesia) to ensure that product or service meets specified requirements.
13. Review method validation study reports, ensure proper documentation of findings, and assist in approval or re-validation recommendations. Prepare summary reports of validation activities, results, and recommendations for management review.
14. Investigate validation failures or deviations, identify CAPA, and ensure implementation. Collaborate with cross-functional teams to enhance the efficiency and effectiveness of validation activities.
15. Identify risks in testing methods, implement mitigation strategies, and ensure data integrity during validation to maintain accuracy, reproducibility, and regulatory compliance.
16. Review and approve method validation documentation, ensuring accuracy, completeness, and compliance with quality standards. Maintain up-to-date records of validation activities, deviations, CAPA, and ensure proper version control for all related documents.
17. Provide training on method validation processes and best practices, and support Production, QC and R&D teams in executing protocols and analyzing data accurately.
18. Any other area of responsibilities that the company deems necessary.
A. QUALITY CONTROL
1. Manage product complaints or non-conformances; thoroughly investigate process failure, determine the root cause, and take prompt corrective actions.
2. Conduct physical, physico-chemical test and microbial analysis of finished product.
3. Track the materials (chemicals and fragrance) that are present in the chemical room and know whether additional supplies need to be ordered.
4. Calibrate all equipment for In-house verification Example – pH meter, weighing scale etc. and arrange external calibration with external party.
5. Train new production operators in quality control.
6. Any other area of responsibilities that the company deems necessary.
B. LIAISE WITH SUPPLIERS (Services):
1. DI Water System Maintenance (Requirements: According to Contract): Loop Sterilization, UV-Lamp etc.
2. Complete Water Quality Testing (annual) by External Lab
3. Monitor the consumable supplies from different suppliers for DI Water (Column, filters, gauges).
4. Wet Wipes Monthly External Microbial testing
5. Monitor the annual cleanroom Certification.
6. External Calibration of Equipment
7. Any other area of responsibilities that the company deems necessary.
C. PRODUCT TECHNICAL SUPPORT
1. Support Export Sales and Marketing for preparation of documentation for regulatory use (COA, Ingredient’s list, FG and RM spec etc).
2. Collaborate with development, QC, and regulatory teams to plan, execute, and review method validation protocols, ensuring compliance with applicable guidelines (e.g., ICH, FDA, EMA) and company procedures, while meeting regulatory standards for intended use.
3. Support on the process validation on the manufacturing of the product.
4. Any other area of responsibilities that the company deems necessary.
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