Quality Director
Wuxi
Mainland China
Posted on: 2024-05-10
Job type: Permanent
Sector: Pharmaceutical and Healthcare
Responsibilities
- To supervise the drug manufacture process and quality management system based on Chinese GMP, EU GMP and related ISO standards, and ensure its effective implementation and regulatory compliance.
- To review and approve quality related documents, including: 1) SOPs and management procedures; 2) Product Manufacture Master Files, including manufacturing formula, processing methods/instructions, quality specifications, testing methods, batch production records, batch packaging records, batch analyzing records, etc.
- To review and approve the sampling, analyzing and evaluation procedures for raw materials, finished products & semi-finished products.
- To review and approve the environment monitoring program and ensure its effective implementation.
- To review and approve the plans, protocols, and reports of validation/qualification & calibration.
- To review and approve significant deviation reports, change controls, and other related technical reports, etc.
- To ensure all relevant customer quality complaints investigated/ handled properly, and effective CAPAs established/implemented.
- To ensure the suppliers evaluated, qualified and audited appropriately.
- To ensure to provide GMP interpretation and conduct GMP training to employees.
- To establish regular contact with competent authorities, to receive GMP and ISO certification inspections at all levels, and prepare and implement CAPAs.
- To supervise the implementation of GMP and ISO standards by all departments and provide guidance. To take charge of management reviews, self-inspections and internal audits, and implementation of relevant CAPAs.
- to prepare the budget and implement the approved budget, including cost, capex and headcount. To achieve the set KPI targets for QM Pharma department.
- Being familiar with the dynamic GMP, ISO standards and other relevant regulations and guidelines, deep understanding of manufacturing processes and quality assurance technologies for Drug.
- Bachelor’s degree or above, majored in pharmaceutical, chemistry, or science & engineering related subjects, etc.
- Good English communication skills.
- Being excellent at continual learning, knowledge application, interpersonal communication, organization & co-ordination, risk assessment, and handling unexpected events.
- Engaged in quality management or manufacturing in pharmaceutical industry over 5 years.
Contact
Sophie Fan
+86 10 5605 5366
Unit 26-27, Level 9, China Central Place Tower 2, 79 Jianguo Road, Chaoyang District
100025 Beijing
Greater China