Quality Control Manager
Negotiable
Responsibilities:
1, under the direct leadership of the quality director, responsible for the overall work of the quality control department.
2, according to the quality standards to organize the preparation of raw materials, intermediate products, semi-finished products, finished products, packaging materials, clean area environmental monitoring inspection procedures, and quality inspection personnel to implement inspection procedures and inspection operations to supervise.
3, responsible for the production process development and verification of the inspection work, to assist the research and development department to do a good job in the verification of some projects.
4. Be responsible for organizing special personnel to do a good job of sample retention observation, and regularly do a good job of sample retention stability inspection test to provide basis for determining the validity period of the product.
5, responsible for the development of inspection equipment, instruments, reagents, test solutions, standards (reference substance), culture medium, drugs and other management procedures.
6, responsible for the accuracy of the inspection results; Responsible for failing to issue the inspection report on time; Responsible for the consequences caused by the quality inspection personnel failing to operate according to the inspection standard operating procedures; Responsible for the inspection accidents of quality inspection personnel.
7. Organize the formulation of various internal control standards, confirmation of testing instruments, confirmation and verification of methodology, entrusted inspection, etc.
8. Participate in the promotion of the approved projects, and actively cooperate with the Project Management Department to do a good job in the deployment and work arrangement of the personnel involved in the projects.
9, responsible for the department's team building and core backbone training, to create an efficient and pragmatic staff team.
10, responsible for the development of the department staff assessment standards, complete the department staff performance assessment.
11, complete the work arranged by the superior leadership.
Job requirements:
1. Have a master's degree or above in medicine, pharmacy or related majors, and have more than 3 years of work experience in drug testing.
2. Be familiar with the laws and regulations of pharmacy and quality, and master the knowledge of molecular biology, cell biology, immunology, microbiology, etc.
3, master the quality management principles, laws, contents, methods, etc., familiar with the pharmaceutical quality control process.
4, familiar with the quality inspection equipment working principle and operation process, understand the production process.
Company address: Floor 4 and Floor 5 (1) of Building 3, Phase 3.1, Wuhan Optics Valley International Biomedical Enterprise Accelerator, 388 Gaoxin 2nd Road, Donghu New Technology Development Zone, Wuhan City
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