Implement standardized procedures of the quality system in compliance with GMP requirements.
Job Responsibilities:
1. Document Management and System Establishment: Organize the compilation, revision and implementation of quality management documents, formulate in-house inspection SOPs, and regularly evaluate the effectiveness and applicability of the quality assurance system.
2. Material Quality Control: Ensure accurate procurement and usage of raw, auxiliary and packaging materials, and assess the quality systems of key material suppliers together with relevant departments.
3. In-process Quality Control: Manage intermediate product control items, promote validation activities, and rigorously carry out in-process inspection, testing, review and deviation handling.
4. Product Release and Non-conforming Goods Disposal: Formulate and administer sampling and retention sample protocols, approve the release of raw & auxiliary materials and finished products, and review disposal procedures for non-conforming items.
5. Quality Stability Assessment: Evaluate the quality stability of raw materials and finished products to provide data for defining material shelf life and product expiry period.
6. Post-market Quality Handling & Record Administration: Handle product returns, recalls and customer complaints arising from quality defects; manage quality documents and original test records to guarantee product quality remains intact during storage, shipment and subsequent handling.
Job Requirements:
1. Bachelor’s degree or above in Chemistry, Pharmacy or other related disciplines.
2. Familiar with lab analysis and testing operations in manufacturers engaged in R&D and production of pharmaceutical intermediates and APIs.
3. Minimum 2 years of quality management experience with full understanding of the entire product lifecycle covering production, testing, release, traceability and product recall.
4. Strong capabilities in planning, execution, communication, organization and coordination.
5. Candidates with experience in on-site GMP certification inspection for pharmaceutical manufacturers are preferred.
