QA 1-1.5万/月

Supplier & Customer Quality Support 1.Support supplier qualification, incoming material quality monitoring, and supplier performance evaluation. 2.Assist in responding to customer quality inquiries, quality questionnaires, and documentation requests (e.g. COA, quality statements). 3.Support customer quality notifications related to changes, deviations, or improvements when required. Quality System & GMP Compliance 1.Support the implementation and maintenance of the site Quality Management System in compliance with GMP, ISO 15378, ISO 9001, and relevant regulatory requirements. 2.Ensure daily quality activities are performed in accordance with approved SOPs, work instructions, and global quality policies. 3.Participate in internal audits, customer audits, and regulatory inspections, including preparation, on-site support, and follow-up actions. 4.Support investigation of deviations, nonconformances, customer complaints, and out-of-specification (OOS) events related to packaging materials. 5.Assist in the initiation, investigation, and tracking of CAPA activities to ensure effective root cause analysis and timely closure. 6.Participate in change control activities related to materials, processes, equipment, suppliers, and documentation. 7.Participate in quality improvement initiatives to enhance process robustness, compliance, and efficiency. 8.Support GMP and quality-related training activities, ensuring training records are completed and maintained. 9.Promote quality awareness and a culture of compliance across operations.

1.Bachelor’s degree or above in Pharmacy, Chemistry, Materials Science, Biology, or a related scientific discipline. 2.3 years or more work experience in Quality assurance. Working knowledge of GMP requirements and quality systems (ISO 15378 preferred) of food, drug or medical device manufacturing. Experience with pharmaceutical primary packaging materials is preferred. 3.Rich multi-department coordination work. Communication skills; Leadership ability; Excellent analysis ability and structured working style. 4.Proficient in 8D, FMEA, HACCP tool. Knowledge of pharmaceutical packaging, medical device (plastic) manufacturing process is preferred. 5.Familiarity with deviation management, CAPA, change control, and document control processes. 6.Good communication skills in both written and spoken English; bilingual (English/Chinese) capability is an advantage. 7.Able to work in competitive environment under pressure. Ability to work independently and collaboratively in a cross-functional environment.

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