QA Specialist

Responsibilities:

1. Responsible for writing GMP-related quality documents. Check the implementation of GMP, SOPs, and other related documents in each workshop.
2. Responsible for the issuance of quality system-related document codes, maintenance, and management of system-related ledgers and records.
3. Responsible for the process of process development, GMP production, QC, material storage, equipment on-site monitoring, ensuring that all key quality control points, hygiene, status indicators, documents, etc., throughout the production process comply with relevant procedures and GMP requirements.
4. Audit GMP-related documents of production upstream and downstream, procurement storage, equipment engineering departments. Participate in the analysis of deviations, non-conformities, changes, risk management in the production process, participate in the investigation and handling of accidents and quality incidents in the production process, and participate in product quality-related risk assessments.
5. Audit the quality standards of raw and auxiliary materials, packaging materials, intermediate products, and raw liquids to ensure compliance with registration and customer requirements.
6. Supervise the maintenance of plants and equipment to maintain good operating conditions.
7. Manage material suppliers, including supplier evaluation, audits, approvals, daily monitoring, and regular assessments, and establish a list of qualified suppliers.
8. Audit production and inspection batch records to ensure that all processes have been completed and qualified before product release.
9. Responsible for tracking and checking internal and external audits in the region, and participate in GMP self-inspection work.
10. Assist in organizing training on drug regulations and GMP basics.
11. Complete other tasks assigned by superiors.