Synthetic developer
- Putian Xiuyu District
- Synthetic developer
- Several
- full time
- Negotiable
- Unlimited
- Undergraduate
- Unlimited
1. Introduction and tracking of new products and processes .
2. Product process optimization .
3. Sample preparation.
4. Organize, analyze and report of experimental data.
2. Product process optimization .
3. Sample preparation.
4. Organize, analyze and report of experimental data.
1.Bachelor＇s degree or above in organic chemistry, applied chemistry, chemical engineering or chemical pharmacy;
2. Experience in the synthesis of organic intermediates of medicine and pesticides is preferred, fresh graduates with excellent academic achievements are also preferred.
3.Knowledge and experience in organic synthesis and analysis ;
4. Good personal quality, high work efficiency and good communication skills;
5. Good self motivation and ability to work under pressure;
6. Experience in organic process development and process scale-up.
2. Experience in the synthesis of organic intermediates of medicine and pesticides is preferred, fresh graduates with excellent academic achievements are also preferred.
3.Knowledge and experience in organic synthesis and analysis ;
4. Good personal quality, high work efficiency and good communication skills;
5. Good self motivation and ability to work under pressure;
6. Experience in organic process development and process scale-up.
HR
0594-5880288-3413
Quality control specialist
- Putian Xiuyu District
- Quality control specialist
- Several
- full time
- Negotiable
- Unlimited
- Undergraduate
- Unlimited
1. Perform product analytical method development and analytical method verification and validation , and routine sample analysis.
2. The testing of raw materials, in-process control samples and finished products, skillfully operate the analytical instruments in the laboratory, and regularly maintain the analytical instruments.
3.Writing reports for experimental pharmaceutical research data, summarizing, analyzing and archiving experimental data, recording original data,to ensure traceability of original data, chromatograms and use records of instruments and reagents.
4. Writing experimental notebook.
5. Establish and implement documentation systems for GMP documents and analytical methods.
6. Perform product research and development, stability test.
7. Complete tasks and assigned by supervisor.
2. The testing of raw materials, in-process control samples and finished products, skillfully operate the analytical instruments in the laboratory, and regularly maintain the analytical instruments.
3.Writing reports for experimental pharmaceutical research data, summarizing, analyzing and archiving experimental data, recording original data,to ensure traceability of original data, chromatograms and use records of instruments and reagents.
4. Writing experimental notebook.
5. Establish and implement documentation systems for GMP documents and analytical methods.
6. Perform product research and development, stability test.
7. Complete tasks and assigned by supervisor.
1. Skilled in LC and other analytical instruments, with relevant working experience in analytical method development.
2. Major in medicine, analytical chemistry, microbiology or related fields.
2. Major in medicine, analytical chemistry, microbiology or related fields.
HR
0594-5880288-3413
Quality assurance personnel
- Putian Xiuyu District
- assurance personnel
- Several
- full time
- Negotiable
- Unlimited
- undergraduate
- Unlimited
1. Prepare documents quality system-related documents.
2. Check and supervise the implementation of GMP, SOP-related at manufacturing sites.
3. Be responsible for process R & D, upstream cell culture of GMP production, downstream purification process, production process, QC, material storage and engineering equipment on-site monitoring to ensure that all key quality control points, hygiene, status identification and documents in the whole production process meet relevant procedures and GMP requirements.
4. Review GMP related documents of upstream and downstream production, procurement, warehousing, engineering equipment and other departments. 5. Participate in the analysis of deviation, nonconformity, change and risk management in the production process, participate in the investigation and handling of accidents and quality accidents in the production process, and participate in the risk assessment related to product quality.
6. Review the quality standards of raw and auxiliary materials, packaging materials, intermediate products and raw liquids to ensure compliance with registration and customer requirements.
7. Supervise the maintenance of plant and equipment to maintain its good operation condition.
8. Participate in material supplier audit, evaluate and approve material suppliers, and establish a list of qualified suppliers.
9. Review the batch production and batch inspection records to ensure that all inspections have been completed and the results are qualified before product release.
10. Be responsible for the follow-up inspection of internal and external audit in the region.
11. Participate in GMP self inspection.
12. Assist and cooperate with other work assigned by QA supervisor.
2. Check and supervise the implementation of GMP, SOP-related at manufacturing sites.
3. Be responsible for process R & D, upstream cell culture of GMP production, downstream purification process, production process, QC, material storage and engineering equipment on-site monitoring to ensure that all key quality control points, hygiene, status identification and documents in the whole production process meet relevant procedures and GMP requirements.
4. Review GMP related documents of upstream and downstream production, procurement, warehousing, engineering equipment and other departments. 5. Participate in the analysis of deviation, nonconformity, change and risk management in the production process, participate in the investigation and handling of accidents and quality accidents in the production process, and participate in the risk assessment related to product quality.
6. Review the quality standards of raw and auxiliary materials, packaging materials, intermediate products and raw liquids to ensure compliance with registration and customer requirements.
7. Supervise the maintenance of plant and equipment to maintain its good operation condition.
8. Participate in material supplier audit, evaluate and approve material suppliers, and establish a list of qualified suppliers.
9. Review the batch production and batch inspection records to ensure that all inspections have been completed and the results are qualified before product release.
10. Be responsible for the follow-up inspection of internal and external audit in the region.
11. Participate in GMP self inspection.
12. Assist and cooperate with other work assigned by QA supervisor.
1. Interested in or familiar with GMP regulations.
2. Microbiology / Biology / Chemistry / pharmacy and other related majors.
2. Microbiology / Biology / Chemistry / pharmacy and other related majors.
HR
0594-5880288-3413
Injection production engineer
- Putian Xiuyu District
- Injection production engineer
- Several
- full time
- Negotiable
- Unlimited
- Undergraduate
- Unlimited
1.Production process and technical management of lyophilized powder for injection.
2.Provide technical support and trouble-shooting for the manufacture of lyophilized powder for injection.
3. Responsible for the quality in the production process.
4. Assist other departments or personnel to continuously improve and innovate the production process to reduce the production cost.
5. Complete the amplification, registration and batch production of prescription process according to the standardized technology transfer requirements.
6. Perform process validation and cleaning validation .
2.Provide technical support and trouble-shooting for the manufacture of lyophilized powder for injection.
3. Responsible for the quality in the production process.
4. Assist other departments or personnel to continuously improve and innovate the production process to reduce the production cost.
5. Complete the amplification, registration and batch production of prescription process according to the standardized technology transfer requirements.
6. Perform process validation and cleaning validation .
1. Major in medicine and pharmacy, with experience in production, operation or management of lyophilized powder for injection.
2. Be familiar with GMP management requirements of injection workshop.
3. Be honest, dedicated, rigorous and serious, and diligent in observation and analysis.
2. Be familiar with GMP management requirements of injection workshop.
3. Be honest, dedicated, rigorous and serious, and diligent in observation and analysis.
HR
0594-5880288-3413
Drug license registrar
- Putian Xiuyu District
- Drug license registrar
- Several
- full time
- Negotiable
- Unlimited
- Undergraduate
- Unlimited
1. Preparation of materials for product registration application.
2. Registration and filing of processes and packaging materials of new products.
3. Gather domestic information on advanced technology development in medical and pharmaceutical industry.
4. Perform literature search on international medical and pharmaceutical journals .
2. Registration and filing of processes and packaging materials of new products.
3. Gather domestic information on advanced technology development in medical and pharmaceutical industry.
4. Perform literature search on international medical and pharmaceutical journals .
1. Careful work and strong sense of responsibility; Experience in drug research and development or drug testing is preferred.
2. Bachelor degree or above, major in biology, pharmacy and other related fields, Pharmaceutical English is preferred.
3. Familiar with word, Excel and other common office software.
2. Bachelor degree or above, major in biology, pharmacy and other related fields, Pharmaceutical English is preferred.
3. Familiar with word, Excel and other common office software.
HR
0594-5880288-3413
Research scientist- formulator
- Putian Xiuyu District
- Research scientist- formulator
- Several
- full time
- Negotiable
- Unlimited
- Undergraduate
- Unlimited
1. Project initiation and other information research.
2. Prescription design, process development, scale-up production,in quality research and troouble-shooting.
3. Sorting, analyzing and reporting original experimental data.
4.Prepare registration application materials in CTD format according to the requirements of current laws and regulations.
5. Maintain and manage laboratory equipment .
6. Complete ad hoc tasks assigned by supervisor.
2. Prescription design, process development, scale-up production,in quality research and troouble-shooting.
3. Sorting, analyzing and reporting original experimental data.
4.Prepare registration application materials in CTD format according to the requirements of current laws and regulations.
5. Maintain and manage laboratory equipment .
6. Complete ad hoc tasks assigned by supervisor.
1. Major in pharmacy, at least 1 year working experience.
2. Be familiar with the R & D process and technical requirements, as well as the operation and principle of equipment.
3. Understand the registration application requirements and guidance.
4. Have strong practical ability and good communication skills and good team playes .
5. Proficient English reading and writing skills.
2. Be familiar with the R & D process and technical requirements, as well as the operation and principle of equipment.
3. Understand the registration application requirements and guidance.
4. Have strong practical ability and good communication skills and good team playes .
5. Proficient English reading and writing skills.
HR
0594-5880288-3413
Validation Specialist
- Putian Xiuyu District
- Validation Specialist
- Several
- full time
- Negotiable
- Unlimited
- Undergraduate
- Unlimited
1. According to GMP regulations, improve the management system related to validation, and determine the validation content and process.
2. Formulate the company's verification plan, coordinate and organize the implementation, and be able to organize and complete the company's verification work.
3. Be responsible for drafting the equipment cleaning verification scheme, knowing the implementation of cleaning verification, and reviewing the verification report.
4. Implement the specific implementation of verification and complete the verification report.
5. Participate in deviation investigation, write or review deviation investigation report, and track the implementation of corrective and preventive measures.
6. Establish and maintain the management account, and keep the processed documents and records.
7. Coordination of affairs caused by superior issuance, change control, deviation investigation and regulatory audit.
2. Formulate the company's verification plan, coordinate and organize the implementation, and be able to organize and complete the company's verification work.
3. Be responsible for drafting the equipment cleaning verification scheme, knowing the implementation of cleaning verification, and reviewing the verification report.
4. Implement the specific implementation of verification and complete the verification report.
5. Participate in deviation investigation, write or review deviation investigation report, and track the implementation of corrective and preventive measures.
6. Establish and maintain the management account, and keep the processed documents and records.
7. Coordination of affairs caused by superior issuance, change control, deviation investigation and regulatory audit.
1. Education / Major: major in electrical, mechanical, mechatronics, electrical automation, etc.
2. At least 1 year working experience in pharmaceutical industry and measurement related work.
3. Trained in GMP and metrology.
4. Strong business processing ability and pressure resistance.
5. Familiar with basic office software.
6. Good language expression and communication skills.
2. At least 1 year working experience in pharmaceutical industry and measurement related work.
3. Trained in GMP and metrology.
4. Strong business processing ability and pressure resistance.
5. Familiar with basic office software.
6. Good language expression and communication skills.
HR
0594-5880288-3413
Microbial Analyst
- Putian Xiuyu District
- Microbial Analyst
- Several
- full time
- Negotiable
- Unlimited
- Undergraduate
- Unlimited
1.Be proficient in using instruments and equipment required for microbial experiment.
2.Preparation of relevant records, reports and other materials according to the requirements of the quality management system.
3. Manage the maintenance and validate instruments and equipment.
4. Sample analysis and technical support.
5. Completed hoc talks assigned by superior.
6. Good communication skills team player and strong work stability.
2.Preparation of relevant records, reports and other materials according to the requirements of the quality management system.
3. Manage the maintenance and validate instruments and equipment.
4. Sample analysis and technical support.
5. Completed hoc talks assigned by superior.
6. Good communication skills team player and strong work stability.
1. Experience in water quality monitoring and sterility testing.
2. Microbiology / Biology / Chemistry / chemical engineering / pharmacy.
2. Microbiology / Biology / Chemistry / chemical engineering / pharmacy.
HR
0594-5880288-3413
Biotechnology Engineer
- Putian Xiuyu District
- Biotechnology Engineer
- Several
- full time
- Negotiable
- Unlimited
- Undergraduate
- Unlimited
1. Responsible for the implementation of production line GMP, production instrument and equipment maintenance, product production operation and relevant GMP specification documents, equipment verification, etc.
2. Be responsible for internal audit and follow-up improvement (annual equipment maintenance plan).
3. Be responsible for the implementation of GMP specifications on the production site, investigate various biases, formulate corrective and preventive measures, determine key risk control points according to the product process, formulate control measures and reduce risks.
4. Draft and review wi / SOP, batch production (packaging) records, management procedures and relevant verification documents, and organize the implementation to complete relevant verification work.
5. Be responsible for implementing the relevant provisions of process procedures, post operation methods and safe operation procedures of instruments and equipment during product production, and timely reporting the quality and technical problems on the production site.
6. Be responsible for recording the operation and maintenance of materials use, consumables use, batch production, personnel access control in the production workshop, equipment use records and other relevant documents in the production process regulations to ensure the stable operation of production equipment.
7. Be responsible for cooperating with R & D to complete the work of new biological drugs, do a good job in the handover of relevant processes, and collect and sort out product data.
8. Complete other tasks assigned by leaders.
2. Be responsible for internal audit and follow-up improvement (annual equipment maintenance plan).
3. Be responsible for the implementation of GMP specifications on the production site, investigate various biases, formulate corrective and preventive measures, determine key risk control points according to the product process, formulate control measures and reduce risks.
4. Draft and review wi / SOP, batch production (packaging) records, management procedures and relevant verification documents, and organize the implementation to complete relevant verification work.
5. Be responsible for implementing the relevant provisions of process procedures, post operation methods and safe operation procedures of instruments and equipment during product production, and timely reporting the quality and technical problems on the production site.
6. Be responsible for recording the operation and maintenance of materials use, consumables use, batch production, personnel access control in the production workshop, equipment use records and other relevant documents in the production process regulations to ensure the stable operation of production equipment.
7. Be responsible for cooperating with R & D to complete the work of new biological drugs, do a good job in the handover of relevant processes, and collect and sort out product data.
8. Complete other tasks assigned by leaders.
1. Biotechnology / bioengineering and other biological related majors.
2. Pharmacy or related major.
3. Familiar with common Bioengineering Equipment.
4. Good communication skills.
2. Pharmacy or related major.
3. Familiar with common Bioengineering Equipment.
4. Good communication skills.
HR
0594-5880288-3413
Research Scientist -Biotechnology
- Putian Xiuyu District
- Research Scientist -Biotechnology
- Several
- full time
- Negotiable
- Unlimited
- Undergraduate
- Unlimited
1. Participate in the R & D of biological drugs under the arrangement of departments and projects, carry out R & D experiments and biological sample analysis, carry out experimental operations and complete experimental reports.
2. Participate in product production process optimization and verification, and assist in product clinical trials.
3. Participate in or assist in the preparation of R & D and production technical data.
4. Participate in some technical support work.
2. Participate in product production process optimization and verification, and assist in product clinical trials.
3. Participate in or assist in the preparation of R & D and production technical data.
4. Participate in some technical support work.
1. College degree or above in biotechnology or medical testing, working experience is preferred.
2. Be familiar with the operation of routine biological experiments and instruments, and master the basic ability to retrieve and analyze documents, patents and other technical data.
3. Enthusiast in R & D and have the spirit of exploration.
4.Good communication skills, sense of responsibility and teamwork spirit.
2. Be familiar with the operation of routine biological experiments and instruments, and master the basic ability to retrieve and analyze documents, patents and other technical data.
3. Enthusiast in R & D and have the spirit of exploration.
4.Good communication skills, sense of responsibility and teamwork spirit.
HR
0594-5880288-3413