Join Us

1、Assist superiors in the construction and continuous improvement of the quality management system, organize the development or audit of various quality system management documents, and maintain the normal operation of the quality system.

2、Participate in the development and implementation of the department's annual and monthly quality work plans; assist superiors in handling the daily work of the department, and assess and evaluate the performance of QA personnel according to performance indicators.

3、Guiding and training QA personnel to carry out various quality management and quality supervision work independently.

4、Responsible for MAH project related material supplier management, establishing supplier files, collating qualified supplier catalogues, participating in supplier audits, tracking audit defects rectification and assessing supplier quality management system.

5、Responsible for the quality audit of MAH project entrusted production enterprises, tracking audit defects rectification and evaluation of the quality management system of the entrusted party.

6、Responsible for the daily interface with the quality department of the MAH entrusted manufacturer, organizing the handling of deviations, OOS, changes, returns, complaints, etc. occurring during the production process, and auditing relevant records.

7、Responsible for the quality management of the whole life cycle of MAH projects, including the quality management during the R&D stage, technology transfer, and market production and sales.

8、Participate in the internal audit of the company's quality system and the special audit of the project.

9、Organize and coordinate the verification, internal rectification and report submission of the pharmacovigilance department.

10、Complete other work assigned by the superior leadership.

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1、Bachelor degree or above, majoring in pharmacy related field.

2、Being engaged in quality management for at least 3 years in joint ventures or  well-known enterprises.

3、Familiar with GMP regulations and the basic process for the  formulation of  productions, experienced national GMP site verification, flight inspection or FDA inspection is preferred.

4、Strong working initiative, good communication and coordination skills, able to respond quickly and coordinate the work of various departments and personnel in a timely manner.

1、Responsible for R&D laboratory site compliance inspection, safety and health inspection.

2、Responsible for the audit of laboratory electronic data, experimental records, instrument use records, material use records, etc..

3、Responsible for the management of the storage and use of materials used in R&D.

4、Responsible for the audit of the completeness, authenticity and standardization of the original record data of R&D.

5、Responsible for the filing and access management of declaration information, original records, diagrams and supporting documents.

6、Drafting of SOP documents for R&D management.

7、Assisting in responding to on-site verification of registration by the National Bureau and customer audits.

8、Assist R&D management manager to complete other related work affairs of R&D management.

1、College degree or above, majoring in pharmacy, applied chemistry, biotechnology and other related majors, with relevant work experience is preferred.

2、Strong awareness and experience in quality management and strong principles.

3、Familiar with domestic and foreign drug management related regulatory requirements.

4、Strong communication skills and strong sense of responsibility.

1、Skilled operation of analytical instruments, such as HPLC, GC, dissolution instrument, electronic balance, etc..

2、To undertake pharmaceutical analysis experiments: method development, product testing and release, method validation and method transfer, stability testing, etc..

3、Specification of writing original records, drafting experimental protocols and writing experimental reports.

4、Other work arranged by the company.

1、College degree or above, pharmaceutical analysis, pharmaceutical engineering is preferred.

2、Skilled in using HPLC or GC analytical instruments, experience in chemical analysis is preferred.

3、Knowledge of national pharmacopoeia, familiar with drug regulations, experience in pharmaceutical companies or drug development is preferred.

4、Serious and careful, good brainstorming, strong sense of responsibility and team spirit.

5、Skilled in using office software, good communication skills and the ability to read and write in Chinese and English.

1、Participate in SOP drafting and daily management system development of the analytical department.

2、Skilled in using, maintaining and calibrating analytical instruments, such as HPLC, GC, dissolution instrument, electronic balance, etc..

3、Independently undertake drug quality research projects: method development, establishment of quality standards, method validation and method transfer, stability testing, etc.

4、Standardized writing of original records, drafting of experimental protocols and reports, and writing of declaration materials.

5、Other work arranged by the company.

1、Bachelor degree or above, majoring in pharmaceutical analysis, pharmaceutical engineering or related fields.

2、Priority for those with training in analytical instruments such as HPLC and regulations such as drug GMP.

3、More than 1 year of analytical work experience, drug GMP experience and CTD data writing experience is preferred.

4、Familiar with national pharmacopoeias, understanding of drug registration declaration process and requirements.

5、Serious and careful, good at brainstorming, strong sense of responsibility, strong R & D dynamic ability and good sense of teamwork.

6、Skilled in using office software, good communication skills and the ability to read and write in Chinese and English.

1、Participate in project research and process route determination; develop process development, impurity research programs, design experiments and make more comprehensive analysis of the results.

2、Complete various chemical unit reaction operations skillfully, complete literature review and graphical analysis independently, participate in the design and optimization of synthetic routes.

3、Rapidly open up the route and complete the development of laboratory small trial process; complete the technology transfer, scaling up, validation and production of API process.

4、Complete experimental records in a clear and complete manner, submit standardized weekly experimental reports on time, and complete R&D reports at all stages in a timely manner.

5、Participate in and support the preparation of API declaration documents and provide the materials required for declaration.

6、Complete the project progress according to the plan, timely report the work progress and problems arising in the subject.

1、Bachelor degree or above in pharmacy, chemistry or other related majors

2、At least two years of relevant work experience

3、Understanding the purpose of reaction, reaction mechanism, familiar with various chemical unit reaction operations, with strong analytical problem solving ability.

4、Strong ability to control the R&D process and strong learning ability.

5、Be able to independently complete literature review and graph analysis, with certain synthetic route design and optimization ability.

6、Knowledge of the writing of process reports and related CTD declaration materials at all stages.

7、Reasonable arrangement of experimental process tasks to improve efficiency and continuous optimization of conditions in the synthesis process to improve the yield.

8、Ability to follow rigorous quality document management and test records, and data analysis specifications.

1、Participate in the formulation of daily management system and standard process of the preparation department.

2、Independent screening and optimization of drug formulation prescriptions and preparation processes.

3、Responsible for the pilot amplification and technology transfer of formulations.

4、Responsible for the writing of R&D original records, declaration materials, reports and experiment-related documents.

5、Organize to overcome technical problems and ensure the smooth progress of the project.

6、Skilled in the use of preparation laboratory instruments and equipment, such as coating machines, tablet presses, granulators, colloid mills, etc..

7、Participate in the daily management within the department.

1、Education level: University degree or above.

2、Major: Pharmacy, pharmaceutical engineering or related majors.

3、Training experience： Training on regulations related to generic drug development, training on the characteristics of prescription process research for various dosage forms, training on formulation quality research, training on data writing requirements for CTD format, etc.

4、Experience ： More than 3 years of relevant working experience.

5、Knowledge: Familiar with the characteristics of solid and liquid formulation R&D, familiar with the regulatory requirements for generic drug registration and declaration, familiar with the professional knowledge of drug formulation R&D, quality analysis and workshop production, familiar with the knowledge of declaration data writing requirements.

6、Skills and techniques: proficient in the use of office software, with basic knowledge of the Internet, a certain level of writing and strong language skills, planning and execution skills, interpersonal communication skills, the ability to operate preparations or analytical equipment, familiar with the new drug development process, and strong research and development capabilities.