1. Assist the department head to complete the inspection of raw materials, packaging materials, intermediate products and finished products, as well as the revision of relevant documents such as instrument and equipment operation procedures;
2. Assist department head to carry out microbiological test, purified water test and maintenance of related instruments and equipment;
3. Assist the department head to carry out the daily environmental detection of the purification area, and issue the report form;
4. Have a certain understanding of the use of the whole set of equipment of water quality and mass spectrometry (water s295) and high performance liquid chromatography (waters 296);
5. Assist the department head to verify the instruments and equipment;
6. Obey the work arranged by superior leaders.
1. Major: biology or pharmacy, chemistry related major;
2. Education background: fresh graduates with college degree or above;
3. Training experience in physical and chemical test, purified water test, microbial test and liquid phase operation;
4. Be familiar with GMP, cGMP or ISO certification;
5. Have good experimental ability and professional quality;
6. In good health, medical report must be provided before employment.
1. Have some management experience;
2. Responsible for the inspection of raw materials, packaging materials and products;
3. Responsible for microbiological testing, purified water testing and maintenance of related equipment; familiar with the generation and management of bacteria;
4. Responsible for the environmental inspection of the purification area and issue the report;
5. Familiar with the use of liquid chromatography-mass spectrometry (water s295) and high performance liquid chromatography (water s296);
6. Draft the verification plan of instruments and equipment, and organize the verification of instruments and equipment;
7. Responsible for the revision of finished product inspection and equipment operation procedures and other related documents.
1. Major: biology or pharmacy, chemistry related major;
2. Education background: college degree or above;
3. Working experience in physical and chemical test, purified water test, microbiological test and liquid phase operation;
4. At least 4 years working experience in medical device or pharmaceutical industry;
5. GMP, cGMP or ISO related certification experience, equipment and instrument verification document preparation and experimental experience is preferred;
6. Physical examination report should be provided before employment.
1. Complete sampling, sterility, microbiological testing and validation of process water, raw materials, intermediate process and finished products as planned;
2. Prepare the medium, buffer solution and general solution used in the experiment according to the plan, and confirm the sensitivity of the medium;
3. Carry out the generation and preservation of strains according to the plan;
4. Complete the revision of SOP for related positions.
1. College degree or above, major in microbiology, pharmacy, biotechnology, etc;
2. At least 1 year working experience in microbiology laboratory in pharmaceutical factory, master basic knowledge and experimental skills of microbiology;
3. Work actively, conscientiously and meticulously.
1. Responsible for novelty search of laws and regulations, analyze and master relevant applicable standards and regulations;
2. Be responsible for the sorting, compilation and application of product registration data;
3. Be responsible for formulating the clinical trial plan and scheme, completing the filing of the clinical trial, and organizing the clinical trial;
4. Assist to complete other registration and certification related matters;
5. Complete other tasks assigned by superior leaders.
1. Major in bioengineering, biomedical engineering, biopharmaceutical engineering or medical device, college degree or above;
2. Understand and be familiar with the domestic class I, II and III registration process and relevant laws, regulations and policies of medical device industry;
3. Familiar with the basic standards of IVD medical devices, more than 2 years of medical device product registration experience is preferred;
4. Good reading and writing skills, language expression and communication skills.
1. According to the characteristics of the product, responsible for the communication and implementation of clinical trials with relevant medical institutions, analysis and summary of test data, etc;
2. Responsible for the communication and implementation of trial production and performance / function testing of products, writing and declaration of registration data, and replying to the supplement opinions of the review department;
4. Responsible for the declaration of intellectual property rights, project awards and certification qualifications of the declared products;
5. Responsible for other related issues in the process of product registration;
6. Complete other tasks assigned by superior leaders.
1. Assist production manager to complete production tasks according to product process and fill in production records;
2. Assist production manager to complete monthly production plan;
3. Be able to use the production equipment according to the requirements of the equipment standard operating procedures, and do a good job in the maintenance of the equipment;
4. Complete other tasks assigned by superior leaders.
1. College degree or above, have certain language organization planning and expression ability;
2. Have some relevant experience, biology, medicine and other professional preferred, have experience in the production and operation of medical devices preferred admission;
3. Familiar with office software;
4. Familiar with the operation and process of in vitro diagnostic reagents and medical devices industry;
5. Self motivated, responsible, good communication skills and teamwork spirit;
6. In good health, provide physical examination report before employment.
1. Implement and improve the company's personnel system and plan, training and development, performance evaluation, employee social security and welfare management;
2. Organize and assist departments in recruitment, training and performance appraisal;
3. Implement and improve the policies and procedures related to employee's entry, employment, transfer and resignation;
4. Staff personnel information management and staff file maintenance, do a good job in staff attendance statistics and other matters;
5. Other personnel daily work.
1. Major in human resource management, engaged in human resource work for more than 1 year, with HR professional knowledge;
2. Have good written and oral expression ability, affinity and service consciousness, strong communication ability;
3. Good computer skills, proficient in office software;
4. Familiar with the relevant national labor laws and regulations, familiar with human resource management workflow and operation mode;
5. Hardworking, meticulous and conscientious work, strong principle, good execution and professionalism.
1. Collect the national, provincial, municipal and other medical, biomedical related fields, and assist enterprises to capture the industry direction;
2. Collect the fund declaration information applicable to enterprises, and track the government support fund policies of Ministry of science and technology, Finance Bureau, economic and Information Commission, science and Technology Commission and regional government;
3. Organize and integrate the company's project application materials according to the project requirements, and participate in the project application, approval and acceptance;
4. Be responsible for the application of enterprise, product and individual honor;
5. Responsible for the docking affairs between the company and intellectual property service agencies, project application service agencies, the government and its relevant departments, and other relevant associations and organizations.
1. College degree or above, with a certain background in Business Administration / administration, working experience in organic chemistry, pharmacy or pharmaceutical related fields is preferred;
2. Be familiar with national and local policies, project application policies and procedures at all levels;
3. Ability to write project declaration independently, fund declaration experience is preferred, drug or in vitro diagnostic reagents, health care products declaration experience is preferred;
4. Good communication skills and team spirit, high sense of responsibility and enterprising spirit.