JOB DESCRIPTION
- Quality Control Inspection
- Issue solution log sheets for compounding.
- Oversee the inspection process for raw materials, packaging materials, chemicals, in-process materials, semi-finished goods, and outgoing finished goods to ensure compliance with specifications.
- Ensure that inspections are conducted based on specified sampling methods and frequencies.
- Release qualified direct materials and finished goods following rigorous quality standards.
- Prepare and maintain product quality documentation based on ISO specifications.
- Develop and review test methodologies, providing necessary training to QC Inspectors when required.
2. Training and Leadership
- Train and motivate the QC team, fostering a positive and professional work environment.
- Conduct GMP, HSE, and Security Threats training for new personnel and annual training for existing staff to ensure awareness and compliance.
3. Compliance and Facility Management
- Conduct regular checks on the cleanliness of the facility, ensuring adherence to GMP standards by production staff.
- Manage pest control program and indoor air quality monitoring.
4. Customer Complaints Handling
- Facilitate meetings with internal departments to resolve product quality issues raised by customers.
- Provide timely updates to customers regarding the status of quality issues.
5. Non-conformance Investigation
- Conduct thorough investigations on non-conformance reports to identify and address discrepancies and deviations from specifications.
6. Product Trials and Issue Resolution
- Actively participate in trial runs of new products, identifying and troubleshooting quality control issues during production.
7. In-house Laboratory Management:
- Oversee and manage the operation of the in-house laboratory to maintain high-quality testing standards.
- Take responsibility for stock inventory of laboratory consumables.
- Schedule and oversee the calibration of equipment to maintain accurate and reliable results.
8. Quality Management System
- Support the maintenance and improvement of quality management systems. Process documents for revision and approval.
9. Reporting and Audit Support
- Prepare monthly QA reports.
- Conduct quarterly 5S / GMP / Process audits and identify areas for improvement.
- Review and approve suppliers, including conducting audits of critical suppliers.
- Support the Senior Quality Manager in internal and external audits to ensure conformity with established quality standards.
10. Digitalization of QC Forms:
- Participate in the setup, implementation and maintenance of digitalized QC forms for efficient and streamlined documentation.
11. Continuous Improvement Initiatives:
- Drive and deliver Continuous Improvement to quantitatively and qualitatively improve efficiency and quality of Kleen-Pak’s operations, products and services.
12. Perform other related duties as required or as directed by the Senior Quality Manager.
JOB REQUIREMENTS
- Bachelor's degree in Chemistry or a related discipline.
- 3 years of hands-on experience in Quality Assurance/Quality Control Processes.
- Proficient understanding of ISO 9000, GMP, and 5S methodologies.
- Certification in ISO 9001:2005 Lead Auditor is advantageous.
- Proven experience in the implementation, maintenance, and improvement of Quality Management Systems.
- Track record of supporting internal and external audits, including supplier audits.
- Experienced in laboratory management, oversight of testing standards, inventory management, and equipment calibration.
- Demonstrated ability to train and lead a team, fostering a positive work environment and ensuring staff compliance with quality standards.
- Strong analytical skills to investigate non-conformances and deviations, troubleshoot quality issues, and implement effective solutions.
- Excellent communication skills, both written and verbal, for facilitating meetings, providing customer updates, and preparing reports.