Job Purpose
- Assist the QA Manager in overseeing in-process inspections, pre-shipment inspections, and incoming packaging checks to ensure consistent product quality. This role supports effective implementation of quality systems and compliance with specifications, regulatory standards, and customer requirements.
Responsibilities
- Oversee in-process (QAI) and pre-shipment (PSI) inspections to ensure compliance with AQL, regulatory, and customer standards.
- Identify and resolve deviations from QA procedures, escalating issues to Production or other stakeholders as needed.
- Review, maintain, and update QA documentation (SOPs, WIs, forms, and records) to ensure accuracy and audit readiness.
- Supervise inspection staff and packaging inspection teams, ensuring competency through training, guidance, and regular performance evaluations.
- Conduct internal audits, root cause analysis (RCA), and lead CAPA processes to address nonconformities and drive continuous improvement.
- Monitor defect and failure trends from QAI/PSI, collaborate with Production and suppliers, and implement corrective/preventive actions.
- Review and approve product disposition in the absence of the QA Manager, ensuring timely release of conforming products.
- Oversee incoming packaging material inspections, liaise with suppliers on quality issues, and manage SCAR processes.
- Coordinate and support external inspections, customer audits, and sterilization dose audits.
- Enforce proper control of inspected goods, equipment calibration, and availability of tools/facilities to maintain safe and efficient operations.
Qualification and Experience
- Bachelor's Degree in Science/Engineering or any related field.
- Minimum of 1 year of working experience in manufacturing environment or fresh graduates.
- Quality control and troubleshooting tools and techniques.
