Quality researcher

• Keep abreast of the latest technical requirements for drug evaluation, and be responsible for the review of related management documents in drug development process, including SOP, methodological validation protocol and report, stability test protocol and report;

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• Responsible for quality research of drug development, including quality standard establishment, analytical method development, analytical method validation and stability study of API and its preparations;

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• Responsible for the analysis and testing of samples during drug development, including raw materials, intermediates, finished products and stability testing, and timely compliance to complete the original experimental records, experimental reports and review;

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• Responsible for the materials, reference materials, reagents, chromatographic columns and other related ledger registration in the research and development process;

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• Complete other daily work and other tasks assigned by superior.

• 1. College degree or above, major in pharmaceutical and chemical engineering, pharmaceutical analysis, instrumental analysis, analytical chemistry, etc.

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• At least 2 years of drug quality research experience, familiar with domestic drug r&d registration and application regulations and procedures, understand ICH and other guidelines;

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• Familiar with registration and GMP requirements in China, Europe and America, experience in quality research of registration project in well-known domestic pharmaceutical enterprises is preferred.

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• Able to independently design test programs and guide quality research, familiar with CTD application materials;

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• Solid theoretical foundation, good experimental operation ability, master the routine maintenance of conventional analysis equipment, skilled in the application of office software such as Office;

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• Good communication and coordination, problem solving and analytical skills, strong sense of responsibility, rigorous and serious work attitude and professional dedication.

Pharmaceutical analysis, pharmaceutical preparation, pharmaceutical chemistry, pharmacy, instrumental analysis, chemical engineering, pharmaceutical engineering, etc

          Pharmaceutical researcher

• Engaged in drug preparation development and research, prescription screening and process optimization;

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• Carry out literature research and develop project research plan under the guidance of superior supervisor;

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• Able to complete experimental work independently, systematically record experimental data and write reports;

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• Complete other daily work and other tasks assigned by superior.

1. Bachelor degree or above, major in pharmaceutical preparation, pharmacy, pharmaceutical engineering or related;

At least 2 years working experience in pharmaceutical preparation research, understand pharmaceutical preparation research process, have certain ability to analyze and solve process problems, understand domestic and foreign r&d guidelines and relevant laws and regulations.

Preferably with injection research experience, excellent conditions can be relaxed;

Familiar with the requirements of Chinese, European and American registration and GMP regulations, experience in drug development of registered projects in well-known domestic pharmaceutical enterprises is preferred.

Proficient in office software;

Good communication and coordination, problem solving and analytical skills, strong sense of responsibility, rigorous and serious work attitude and professional dedication.

Pharmaceutical analysis, pharmaceutical preparation, pharmaceutical chemistry, pharmacy, instrumental analysis, chemical engineering, pharmaceutical engineering, etc

            QA manager

• Responsible for the operation of the company's quality system, responsible for organizing and coordinating the quality management related work of each department, to ensure the effective implementation of each department in accordance with relevant GMP regulations and requirements of the company's quality system;

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• Responsible for drafting, reviewing and issuing quality system documents of each product;

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• Responsible for the management of changes, deviations, OOE/OOS/OOT/ nonconformance, complaints/returns/recalls, validation and original records related to each product project;

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• Responsible for the preparation and accompanying inspection of official and customer audit, the formulation and implementation of corrective measures for existing problems;

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• Complete other daily work and other tasks assigned by superior.

Bachelor degree or above in pharmaceutical related field, master degree is preferred, or experience in pharmaceutical r&d and quality research is preferred;

Familiar with Chinese, European and American registration and GMP requirements, quality management experience in a well-known pharmaceutical company is preferred.

NMPA/FDA/EDQM official audit experience is preferred;

Proficient in office software;

Good communication and coordination, problem solving and analytical skills, strong sense of responsibility, rigorous and serious work attitude and professional dedication.

Major in English or other foreign languages, pharmaceutical analysis, pharmaceutical preparation, pharmaceutical chemistry, pharmacy, instrumental analysis, chemical engineering, pharmaceutical engineering or related pharmaceutical chemical engineering

            Registration manager

Complete part of the research and evaluation related to the project approval of new products;

Make budget, plan, progress tracking and summary of registered projects;

Responsible for the preparation and review of drug registration application materials, and ensure the completion of the application within the specified time;

Responsible for product registration application, on-site inspection, registration inspection, data supplement and other related work coordination and preparation and progress tracking;

Provide technical support for the whole process of product registration for r&d and quality departments;

Maintain good relationship with drug regulatory department and relevant government departments;

Timely informed of national pharmaceutical, registration and other policies, regulations, reform information, and timely and effective transmission of new regulations and adjustment department work; Track, collect and sort out the latest requirements of foreign pharmaceutical laws and regulations and medical information, provide services and guidance to other departments of the company;

Complete other daily work and other tasks assigned by superior.

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• Bachelor degree or above in pharmaceutical related field, experience in pharmaceutical r&d and quality research is preferred;

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• At least 3 years working experience in drug registration and management, or drug r&d and quality research experience is preferred;

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• Familiar with the requirements of Chinese, European and American registration and GMP laws and regulations, with relevant registration and declaration experience in well-known domestic large pharmaceutical enterprises is preferred;

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• Familiar with the procedures and procedures of drug registration and application, familiar with the writing of application materials and the ability to review the application materials;

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• Cet 6 or above;

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• Proficient in office software;

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• Good communication and coordination, problem solving and analytical skills, strong sense of responsibility, rigorous and serious work attitude and professional dedication

Major in English or other foreign languages, pharmaceutical analysis, pharmaceutical preparation, pharmaceutical chemistry, pharmacy, instrumental analysis, chemical engineering, pharmaceutical engineering or related pharmaceutical chemical engineering