Human resources strategy
Here you will work with your colleagues to develop your talents and abilities. Your ability to work and your spirit of innovation are bound to come in handy. If you are performing well, you will be given the opportunity to be promoted to become an outstanding person. We wish you to develop together with us and create a beautiful and prosperous Yakang!
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The company will provide you with an excellent job development platform, perfect personal development and training opportunities, so that you will continue to progress in the future work to achieve maximum value.
1, presided over the work of the Department of Clinical Medicine;
2. To guide the design and formulation of new drug clinical research programs and related documents, and to communicate with clinical experts to modify and improve; and to ensure the effective implementation of clinical protocols at the research base;
3. Responsible for organizing and presiding over clinical program discussion meetings and summaries, analyzing statistical data, writing clinical trial reports and research findings;
4. Responsible for establishing the quality system of clinical research project management;
5. Responsible for the training and management of the staff of the subordinates; leading the research team to ensure that the test is completed in accordance with the expected time and high budget cost;
6. Host regular internal team meetings to inform the progress and problems of the trials and report to the superiors;
1. Has a medical background and holds a doctorate in clinical medicine or clinical pharmacology;
2. Have working experience in relevant fields of drug clinical research, and those who are responsible for the complete clinical research projects of innovative drugs I to III are preferred;
3. Be familiar with the writing of relevant materials for clinical trials I, II, III, and IV;
4, participated in the new drug review meeting, familiar with the drug trial center's focus on new drugs;
5, has a strong execution, sense of responsibility, active thinking, with innovative thinking and teamwork spirit;
1. Proficiency in drug clinical trial programs and audit points.
2. Assist the audit manager to do the training before the clinical auditors start the trial.
3. Do a good job in the inspection of drug clinical trials.
4, do a good job in the inspection of drug clinical trial data.
5. Conduct real-time audits of clinical research and fill in visit/audit reports in a timely manner.
1. Be familiar with the writing of relevant materials for clinical trials I, II, III, and IV;
2. Participated in the new drug review meeting, familiar with the content of the drug trial center's concern for new drugs;
3, has a strong execution, sense of responsibility, active thinking, with innovative thinking and team spirit;
1. Responsible for material inspection and testing, data recording and analysis;
2. Responsible for analyzing and summarizing the abnormal data in the experimental data and experimental process to ensure timely release of the product or timely completion of the project;
3, design, preparation of operating procedures, guidance documents and record formats;
4, responsible for online product pharmacopoeia and customer, materials, technical transformation and other analytical methods to confirm;
5. Draft the verification plan, implement analysis method verification and complete the test report;
6. Coordinate the transfer and confirmation of new product analysis methods;
1, pharmaceutical analysis, pharmacy, applied chemistry and other related professional, bachelor degree or above;
2. More than three years of analytical work experience in the pharmaceutical industry;
3. Have received training in EHS, GMP, job skills, pharmacopoeia, etc. in the pharmaceutical industry;
1. According to the project research and development plan, compile individual work plans and constantly check the implementation of the plan, and make a cause analysis and experience summary;
2. To carry out research and development of the project in accordance with the established plan, and timely and efficiently complete the assigned research and development tasks;
3, master the principle of commonly used analysis equipment and can be used proficiently (common analytical instruments such as HPLC, GC, UV, etc.);
4, in accordance with GMP and EHS standard system and other rules and regulations, do a good job of equipment maintenance and maintenance work;
5. Responsible for dealing with the technical problems encountered in daily work and analysis of causes of deviations;
6. Complete other tasks assigned by superiors;
1. Chemical and pharmaceutical engineering and related majors;
2. More than 1 year relevant work experience;
1. Execute inspection and record of the controlled materials;
2. Participate in the investigation of abnormal events (deviations, OOS/OOT, complaints, etc.);
3. Participate in audit related analysis and inspection;
4. Participate in the drafting of relevant operating procedures and analysis method documents;
5, there are analytical work experience is preferred;
1, pharmaceutical analysis, pharmacy, applied chemistry and other related professional, secondary school education or above;
2. More than one year of analytical work experience in the pharmaceutical industry;
3. Those who have received training in EHS, GMP, job skills, pharmacopoeia, etc. in the pharmaceutical industry are given priority;
1. Strictly follow the post SOP operation, complete production tasks in time, and earnestly implement the 6S management regulations;
2. Daily maintenance of production equipment;
3. Strictly implement the production safety management system and implement the workshop production safety plan;
4, do a good job related production records;
1. High school, secondary school or above, willing to work in frontline workshops;
2. Under 35 years of age, hard-working, strong sense of responsibility;
3, can adapt to four shifts and three operations, with relevant work experience is preferred;