CAREER DEVELOPMENT
Careers
NO1 /QA Verification Engineer
Responsibilities:
1. Responsible for the preparation and implementation of the verification plan of each project, and draft the verification plan and verification review report every month.
2. Responsible for the drafting, implementation and updating of verification confirmation and verification related documents, and updating of verification deviation and change account.
3. Participate in the investigation and analysis of deviation and evaluation of change in the validation process.
4. Be responsible for the utility system
5. Audit the verification documents of the original solution, preparation production process equipment and process equipment, audit the equipment risk assessment, urs, DQ, IQ, OQ, etc., and supervise the implementation of verification;
6. Responsible for the verification document audit of ctus equipment, supervise the implementation and tracking, draft verification documents and participate in the implementation of verification work when necessary.
7. Carry out and promote relevant computer verification according to the requirements of China's new GMP, EU GMP and FDA;
Requirements:
1. Major in pharmacy, biology and pharmacy, college degree or above;
2. Have at least 2 years of verification experience in pharmaceutical manufacturing enterprises;
3. Have professional knowledge of drug production, familiar with GMP related laws and regulations at home and abroad, and familiar with GEP and industry standards;
4. Proficient in using office software, operating Kaye verifier and other equipment is preferred;
NO2 /R&D QA Specialist
Responsibilities:
1. Audit the experiment record book and other original data according to SOP or experiment plan (if any); audit and confirm the batch production record and batch inspection record;
2. Audit quality standard, stability test plan / report, process / method verification plan / report, COA, etc. according to SOPs;
3. Assist and participate in making annual audit plan, conduct internal audit according to SOP, follow up, coordinate and implement corrective and preventive measures, and promote continuous improvement of quality management system;
4. Manage laboratory deviation, CAPA (rectification and prevention), change investigation and tracking;
5. Participate in the planning, establishment, improvement, updating and maintenance of the company's quality management system related SOPs; organize relevant personnel to review and approve the quality system documents to ensure that they comply with policies, regulations and international standards;
6. Responsible for the company's file management, including the distribution, registration, filing and preservation of batch records and experimental records;
7. Assist and participate in the formulation of annual training plan, coordinate and organize training, and manage personnel training files (including resume, job responsibilities, training plan, training records, etc.);
8. According to the company's SOPs requirements, assist and participate in the development of supplier audit plan, organize and implement the third party (Supplier) audit or evaluation, and manage and maintain the supplier list;
9. Support on-site verification by regulatory authorities.
10. Finish other work arranged by superior leaders.
Requirements:
1. Bachelor's degree or above in pharmacy, biology, chemistry or equivalent major, with professional knowledge of biological products;
2. Strong communication skills and learning ability, serious work, strong sense of responsibility, strong executive power;
3. Have a good sense of teamwork and team spirit, willing to share information, to achieve win-win team;
4. Familiar with office software;
5. QA experience is preferred.
NO3 /Clinical project manager
Responsibilities:
1. Responsible for making work plan, schedule and budget, and ensuring quality management during implementation;
2. Keep good coordination with all cooperators and test bases;
3. Be responsible for the implementation and supervision of specific clinical trials to ensure that clinical trials are carried out according to standard operating procedures;
4. Participate in the preparation of technical documents related to clinical trials;
5. Preliminary review of clinical research reports;
6. Coordinate the overall progress of the project, grasp the project time node.
Requirements:
1. Master degree or above is preferred;
2. Clinical medicine, pharmacy related majors,
3. More than 2 years working experience in clinical trials
4. Good basic knowledge of clinical medicine and pharmacy;
5. Familiar with drug registration, GCP and other industry policies, regulations and technical requirements;
6. Strong project planning and control, organization and coordination, time management and learning ability
NO4 /Technology transfer researcher
Responsibilities:
1、 Process research
Responsible for process development and optimization
Participate in project introduction and technology transfer
2、 GMP production
1. Responsible for process development and optimization
2. Participate in project introduction and technology transfer
3. Responsible for the operation of downstream processes, including buffer preparation, chromatography, virus inactivation / removal, etc;
4. Draft SOP and batch record
5. Responsible for the daily maintenance of related equipment
6. Responsible for equipment confirmation and reconfirmation
Qualifications:
1. Bachelor degree or above, majoring in biology, pharmacy or chemical engineering. 211 university or above is preferred
2. They are in good health and meet the requirements of GMP for physical examination of drug practitioners
3. Master degree 1-2 years or bachelor degree 3-5 years purification experience in genetic engineering pharmaceutical company
NO5 /Clinical supervisor
Job responsibilities
1. Carry out test supervision according to GCP and SOP of the company;
2. Responsible for monitoring the quality of clinical research, tracking the progress of research and participating in the coordination of clinical trials;
3. Ensure that the research data are timely, accurately and completely recorded in the case report form, and assist the research center to solve the problems that may occur during the trial;
4. Report the progress of the research center to the leader in charge in a timely and comprehensive manner;
5. Assist the leader in charge to complete the sample distribution, contract payment, summary report seal and other work.
Qualifications
1. Bachelor's degree
2. Major in clinical medicine and pharmacy
3. Clinical research experience is preferred
NO6 /Downstream technician
Job description
1. Responsible for the operation of downstream processes, including buffer preparation, chromatography, virus inactivation / removal, etc;
Responsible for the statistics of related consumables and raw materials
Responsible for the daily maintenance of related equipment
Responsible for equipment confirmation and re confirmation
Qualifications:
1) Experience in Akta or other protein purification chromatography equipment
2) Optimization and validation of inactivation / virus removal process
3) Experience in chromatographic process development, amplification, optimization and validation is preferred
4)Familiar with office software
5)Be familiar with GMP knowledge of pharmaceutical factory
Good communication and logic skills, with the ability to analyze and deal with abnormal situations
NO7 /Instrument analyst
Responsibilities:
1, undertake protein physicochemical analysis, such as protein expression detection, volume exclusion method to detect protein purity, capillary electrophoresis electrophoresis to detect protein purity, ion exchange chromatography detection of protein charge heterogeneity content, protein peptide analysis, protein and other electrical point detection methods.
2. Undertake the optimization and transfer of physical and chemical analysis methods, draft method SOP;
3. Responsible for the management and maintenance of physical and chemical analysis instruments such as HPLC / UPLC / CE, to ensure that the operation of instruments and equipment meet the requirements of SOP;
4. Responsible for OOS / OOT investigation of physical and chemical laboratory.
Qualifications:
1. Bachelor degree or above in analytical chemistry;
2. At least one year working experience in instrument analysis in pharmaceutical company is preferred;
3. Familiar with liquid phase operation is preferred;
4. Good command of English listening, speaking, reading and writing;
5. Strong logical ability, good analytical and communication skills.
NO8 /Preclinical pharmacology and Toxicology Research Specialist
Responsibilities:
1. Responsible for consulting literature, participating in the trial scheme of preclinical pharmacology, efficacy, pharmacokinetics, safety evaluation and other related research, communicating and coordinating with cro and other business units and management departments to ensure project progress and research quality;
2. Responsible for tracking the results of research data analysis and processing, organizing and coordinating relevant personnel to discuss the research results, and formulating the next research content;
3. Be responsible for the project progress and grasp the schedule at any time;
4. Cooperate with registration and declaration personnel to collect relevant information;
5. Other work arranged by superior leaders.
Requirements:
1. Bachelor degree or above, major in pharmacology, pharmacy, biology, medicine, etc., with solid professional knowledge;
2. Have a certain understanding of R & D and development mode of new drugs, and have a certain understanding of regulations and guiding principles of CFDA and other institutions;
3. Good English, be able to conduct product research, translate and write professional literature;
4. Strong sense of responsibility, strong execution and good professional ethics;
5. Computer requirements: master the basic knowledge of computer, be able to skillfully operate the Chinese and English operating system, and master the application of office automation software.
6. Experience requirements: relevant experience is preferred, willing to provide systematic training for the inexperienced.
7. I want to work hard in the field of preclinical research.