Jinan Shi, 上海, 中国
This role will lead the QA of company's genetic manufacturing BU, reporting to Plant Operation GM.
Our Client belongs to a top China manufacturing group, focusing on chemical drug product development, production and sales. With rapid growth in global market, two of the subsidiaries have got listed. The group is now in aggressive expansion in genetic manufacturing. All subsidiaries and its products are GMP approved.
* Understand the US FDA cGMP system and have a practical experience in system certification.
* Responsible for the formulation of annual work plan and implementation, development of QA personnel assessment procedures and assessment.
* Responsible for organizing the supervision and inspection of the implementation of quality control standards.
* Responsible for the organization of the quality of the initial supplier of material audit work, and is responsible for drafting the audit report.
* Responsible for the organization of the company's production and sales process quality control.
* Responsible for the issuance of materials (including the starting materials, packaging materials, finished products), batch release audit.
* Responsible for the supervision and inspection of cGMP implementation.
* Responsible for all kinds of personnel of the Company SOP, GMP training and education.
* Responsible for finished product return / recall processing, customer complaint handling and adverse drug reactions.
* Responsible for tracing the cause of the quality of the accident and put forward opinions.
* More than 8 years working experience in FDA certified pharmaceutical company.
* Have the QA management experience in the pharmaceutical industry, familiar with business processes and related knowledge, served as QA manager for more than 5 years