1.Understand and familiar with GMP regulatory requirements, familiar with deviation, change, OOS/OOE, quality event process and management.2.Responsible for drafting and reviewing API production control documents. Review technical documents such as batch records, process validation programs/reports, transfer programs/reports. Participate in the review of registration documents.3.Responsible for solving quality problems in the production process with the production department.4.Responsible for customer complaints and non-conformities, reworks, returns.5.Participate in internal and regulatory department inspections, participate in self-inspection and daily business link optimization and improvement.6.Responsible for the release of intermediates, raw materials, packages or finished products if authorized.7.Responsible for annual product review.