Yiruida attaches great importance to talent cultivation and human capital investment. The company takes it as its responsibility to provide employees with opportunities and space for sustainable development.
According to the company's strategic development needs and employee training needs, a series of trainings will be provided to create conditions and opportunities for sustainable development of employees.
The company has designed a "dual channel" development model for each employee's development, one of which is a specialized and in-depth development path, known as the professional channel.
The other is the development path in management positions, which is the management channel. Employees can accumulate their own experience and choose different development paths for the company according to their objective reality.
1. Assist in the formulation and regular updating of the company's inspection plan (including test-related inspection and system inspection), and maintain close cooperation with the quality assurance (QA)/quality management (QM) department of the client to assist in the completion of relevant QM/QA plans;
2. Plan, prepare and assist in the implementation of internal system inspection, experimental document inspection (including PRT, ICF, summary report and other relevant information), CRO inspection of research institutions and external entrusted business, and preliminary inspection before inspection, report the inspection results and ensure that the inspected unit has taken appropriate Inspection measures;
3. Assist in the inspection and third-party inspection of the drug administration authorities;
4. Assist the QM manager in reviewing and approving the SOPs/WPs of each department of the company, and participate in the review of Global SOPs to ensure consistency of the content;
5. Assist in the production and revision of the company's common SOPs/WPs and quality management room SOPs/WPs and conduct relevant training;
6. Coordinate the training of other relevant SOPs/WPs, GCP and applicable regulations;
7. Keep the company's SOPs/WPs originals, SOPs/WPs training records and other relevant documents;
8. Maintain communication with clinical developers, participate in relevant project meetings, keep abreast of the progress of the project and assist in solving practical problems.
1. Clinical medicine or pharmacy and other related majors, bachelor's degree or above;
2. At least 2 years of relevant work experience in the clinical development of new drugs, pharmaceutical registration, international clinical development experience or quality management related experience are preferred;
3. Strong understanding ability, efficient and flexible handling of affairs, strong communication and coordination ability;
4. Proficient in operating common office software such as MS-office, especially Word, Excel and PowerPoint;
5. English level 6 or above, fluent in spoken language, can be used as a working language;
6. High comprehensive quality, good appearance, good etiquette cultivation;