Major responsibilities

• Responsible for QC sample management, including drafting sample management procedures; sample receipt, verification, distribution, retrieval, and disposition.
• Responsible for QC record management, including issuance, verification, distribution, retrieval, and compliance review of records.
• Responsible for Certificate of Analysis (COA) related work, including drafting COA management procedures, issuing COAs, and arranging approvals.
• Responsible for QC document management, including document effectiveness activation, issuance, placement, and retrieval.
• Responsible for stability studies, including drafting stability management procedures, annual stability study plan development, execution tracking, and data consolidation.
• Responsible for management of QC reagents and reference standards, including drafting management procedures; requisition, verification, receipt, storage, issuance; periodic inventory; and handling of expired reagents.
• Responsible for management of precursor chemicals, explosive-prone substances, and highly toxic substances, including requisition, verification, receipt, storage, issuance; periodic inventory; and handling of expired reagents.
• Responsible for abnormality investigations, including drafting management procedures; ledger management; issuing investigation numbers; progress tracking; and management of investigation reports.
• Responsible for management of QC outsourced testing, including contract applications, order issuance, progress tracking, and report confirmation.
• Responsible for QC fixed asset management, including updating summary lists and organizing/assisting Finance with periodic inventory counts.
• Responsible for tracking completion of QC qualification/fit-for-work certifications and organizing department-level training across QC groups.
• Comply with the Good Manufacturing Practice (GMP) for Pharmaceutical Products (2010 Edition), the Requirements for Pharmaceutical Records and Data Management (Trial), and company policies on data integrity to ensure data integrity: (1) When completing and reviewing/auditing records (including electronic and paper records), ensure all records and data meet ALCOA+CCEA requirements, take measures to prevent any form of data falsification, and ensure authenticity and reliability of data. Promptly report any data reliability issues to the direct manager or QA; (2) Attend data reliability-related training on schedule to increase awareness of the importance of data reliability.
• Conduct QC laboratory compliance inspections and guide teams to complete corrective actions on time.
• Participate in internal and external audits conducted by the company and complete related corrective actions according to requirements and schedule.
• Complete other tasks assigned by the manager in a timely manner.

Education, Qualifications, Skills and Experience

• A bachelor’s degree or higher  in Pharmacy, Biology, Pharmaceutical Engineering, or related fields.
• At least three years of experience related to pharmaceutical quality.
• Proficient in using computers and Microsoft software.
• Familiar with GMP regulations and guidelines, various national pharmacopoeias, and quality management systems.
• Familiar with guidance related to sample management, document management, stability studies, and OOS (Out of Specification).
• Strong organizational, communication, and teamwork capabilities, with well-developed interpersonal skills to interact effectively across multiple teams.
• Possess English listening, speaking, reading and writing skills.