Job responsibilities:

1. Strictly follow the job SOP for operation, regularly patrol the operation of boiler equipment and instruments according to the specified route and time. If defects or equipment malfunctions are found, measures must be taken to eliminate them and timely report them. Keep all records on time.

2. Collaborate with maintenance or repair personnel to handle issues during equipment maintenance and repair. If the equipment malfunctions or cannot operate, it should be promptly resolved. If it cannot be resolved, it should be immediately reported to the superior leadership.

3. Fully responsible for the monitoring and adjustment of boiler startup and shutdown operations, as well as the reasonable allocation of steam and hygiene work within the responsible area, to ensure the safe and economic operation of the boiler.

4. Responsible for inspecting the operation equipment (such as the reliability of safety valves) to ensure the safe operation of the boiler.

5. Responsible for the statistical work of energy instruments related to energy conservation and consumption reduction.

6. Assist sewage posts in conducting holiday and night inspections.

7. Strictly control material consumption and manage spare parts.

8. Responsible for the hygiene and equipment cleaning work in the job area.

9. Professional knowledge training for new personnel.

10. Complete other temporary tasks assigned by superiors.

Qualification:

· Education requirements: Technical secondary school or above

· Professional requirements: Electrical and electromechanical related majors

· Work experience: At least 1 year of relevant experience

· Skill requirements: Boiler operation qualification certificate, water quality verification

Job responsibilities:

1. Responsible for project research, completing the search and retrieval of Chinese and foreign literature, pharmacopoeia, and other materials.

2. Responsible for the development and methodological validation/transfer of analytical methods for raw materials and formulations, and completing quality research and stability of drugs research.

3. Responsible for arranging the work of the analysis team, drafting research and development project plans, supervising the execution of plans, and effectively controlling progress.

4. Participate in the formulation of quality standards and the drafting of relevant registration and application documents.

5. Participate in the creation and improvement of laboratory SOP procedures to ensure compliance with FDA regulatory requirements.

6. Assist in daily laboratory management and investigation of OOS and deviations.

7. Responsible for daily management and maintenance of experimental instruments and equipment.

R&D Analysis Director

Job requirements:

1. Bachelor degree or above in pharmacy, pharmaceutical analysis, Analytical chemistry and other related majors.

2. Have at least 5 years of experience in developing analytical methods; Experience in cGMP work in pharmaceutical companies is preferred.

3. Have led the development of analytical methods for research and development projects, and those with experience in developing multiple dosage form analysis methods are preferred.

4. Be able to skillfully read Chinese and English literature, retrieve and translate domestic and foreign technical data, and independently carry out research on drug quality standards.

5. Proficient in the use and maintenance of various analytical instruments such as HPLC, GC, ICP-MS, UV, infrared, etc.

6. Understand the drug application process, drug inspection and registration, and be able to control the research progress of the project.

7. Possess strong analytical expertise, good coordination and communication skills, strong sense of responsibility, professional dedication, and enthusiasm for engaging in research and development of drug analysis.

Job responsibilities:

1. Strictly follow the job SOP for operation, responsible for the operation and troubleshooting of purified water preparation system, injection water preparation system, pure steam generator, air conditioning, electric refrigeration unit, compressed air, ozone and other equipment, and keep records of equipment operation and spot checks, and be responsible for archiving on a monthly basis.

2. According to the operating SOP regulations, sample purified water, injection water, and pure steam condensate, and conduct routine inspections on the water samples in a timely manner, and keep water quality inspection records according to the actual situation.

3. Responsible for replacing the initial, intermediate, and efficient components, cleaning the chassis, keeping timely records, and summarizing and archiving them.

4. Strictly control material consumption and manage spare parts.

5. Responsible for the periodic work of factory related inspections.

6. Responsible for the hygiene and equipment cleaning work in the job area.

7. Responsible for drafting and revising GMP related documents.

8. Professional knowledge training for new personnel.

9. Complete other temporary tasks assigned by superiors.

Qualification:

· Education requirements: Technical secondary school or above.

· Professional requirements: Chemical and electromechanical related majors.

· Work experience: At least 1 year of experience in the operation and maintenance of public engineering equipment.

· Skill requirements: Familiar with Word, Execl, and other related software.

Job responsibilities

1. Strictly follow GMP requirements and relevant operating procedures for production operations.

2. Proficient in operating aluminum plastic packaging lines and bottle packaging lines, with the ability to troubleshoot common faults. And can carry out related work such as FAT, SAT, IQ, OQ, PQ, etc.

3. Strictly follow the relevant SOP to operate production equipment, maintain and maintain the equipment, and ensure its safe operation.

4. Fill in batch production records and corresponding auxiliary records in a timely and truthful manner as required.

5. Able to independently draft relevant documents for this position.

6. Complete the archiving of batch records and auxiliary records for this position on time.

7. Complete other tasks assigned by superiors.

Job requirements:

1. Full time college degree or above, major in pharmacy and machinery is preferred.

More than 2.3 years of experience in packaging operation.

3. Familiar with the knowledge requirements related to drug GMP, have participated in the GMP certification of oral solid preparations, and have experience in FDA certification is preferred.

4. Master commonly used office software such as Office.

5. Good communication and coordination skills, as well as team spirit.

6. Strong execution ability, strong sense of responsibility, honesty and dedication, strong resistance to pressure, and adaptability to overtime.

Job responsibilities:

1. Proficient in operating capsule filling machines, with the ability to troubleshoot common faults; I have participated in the verification work of FAT, SAT, IQ, OQ, PQ and other related equipment for the position.

2. Able to independently draft relevant documents for this position.

3. Be able to safely and orderly complete the production tasks of the team, and ensure that all operations are carried out in accordance with relevant SOPs.

4. Standardize the filling of production records, auxiliary records, vouchers, and documents for this process, responsible for the initial review of records and timely submission.

Qualification:

· College degree or above, major in pharmacy and mechanical engineering is preferred.

· More than 2.3 years of experience in filling operation.

· Master commonly used office software such as Office.

· Strong execution ability, strong sense of responsibility, honesty and dedication, strong resistance to pressure, and adaptability to overtime.

· Familiar with the knowledge requirements related to drug GMP, have participated in the GMP certification of oral solid preparations, and have experience in FDA certification is preferred.

Job Deion:

1. Responsible for the network construction and management of the company's newly built factory buildings.

2. Responsible for the maintenance of the company's IT system, including e-mail system, nail system, Door security, monitoring system, etc.

3. Ensure the daily operation and maintenance of the company's data center computer room, regularly backup, control data security, optimize data, and set permissions.

4. Ensure the normal operation of various basic office software and hardware, networks, servers, etc. of the company, and ensure normal office needs.

5. Procurement, installation, and maintenance management of IT assets and accessories.

6. Draft relevant systems for company information management.

Job requirements:

· Bachelor's degree or above, majoring in computer related fields.

· More than 5 years of IT work experience, with at least 3 years of IT operation and maintenance experience in pharmaceutical companies preferred.

· Proficient in commonly used software and hardware knowledge, with experience in debugging and managing network devices such as firewalls, routers, and switches such as Cisco, Huawei, and H3C, capable of independent troubleshooting and maintenance.

· Familiar with information security, with rich management experience in network security, terminal security, data security, application security, etc.

· Having a certain level of writing skills, able to write management documents, operation manuals, etc.

· Good at communication, honest and reliable, with a good team spirit, a high sense of responsibility, and a good sense of service.

Job responsibilities:

1. Responsible for the company's quality assurance management work, including passing the US FDA GMP and China GMP quality management system;

2. Ensure the establishment, implementation, and maintenance of the company's quality system, and fulfill the quality veto power;

3. Responsible for formulating relevant quality policies and operating standard procedures;

4. Organize internal self inspection and external quality audit of the enterprise's quality system;

5. Be responsible for verifying and reporting adverse drug reactions, handling customer complaints, CAPA and Product recall and other quality management activities, and tracking the improvement of the quality system;

6. Responsible for product release, ensuring that the production and inspection of each batch of released products comply with relevant regulations, drug registration requirements, and quality standards;

7. Participate in supplier audits, selection of production process equipment, mechanical and electrical purification, and technical negotiations during the company's construction period, and conduct risk assessment and control from a quality assurance perspective.

8. Participate in determining supplier review results, control and manage supplier supply quality and cost improvement;

9. Participate in receiving, verifying, and improving existing processes for new products and new process materials, and review technical archives;

10. Go deep into the production site, conduct risk analysis and control on the production site, regulate quality disputes, investigate and analyze major quality accidents, and propose solutions;

11. Responsible for conducting quality supervision in accordance with company policies and relevant regulations;

12. Responsible for on-site training of the company's overall GMP regulatory knowledge and skill training for quality personnel on-site management;

13. Maintain good interaction and collaboration with relevant drug regulatory units, and establish a consultation platform for technical issues between the company and regulatory units.

Job requirements:

1. Have at least a bachelor's degree in pharmacy or related majors;

2. Have at least five years of practical experience in drug production and quality on-site management, and have been engaged in the production process control and quality inspection of sterile pharmaceutical preparations;

3. Participated in specific tasks such as equipment selection, risk assessment, and equipment verification for newly built factories;

4. Have the ability to draft and approve relevant validation plans for sterile formulations, oral formulations, BFS, and other dosage forms;

5. Have a deep understanding and sufficient application knowledge of Chinese GMP, FDA, EU and other regulations;

6. Experience in conducting factory inspections through FDA pharmaceutical factories in the United States is preferred;

7. Have good communication and coordination ability, strong executive power, rich management experience, and strong public handling and contingency capacity;

Excellent Chinese and English speaking and writing skills are preferred.

Job responsibilities:

1. According to the operating procedures, execute the control, copying, distribution, archiving, recycling, and destruction of documents;

2. Responsible for document numbering management and document format review;

3. Responsible for the distribution, recycling, and archiving of GMP records.

4. Responsible for the archiving, preservation, and borrowing management of GMP related archives;

5. Responsible for organizing training related work, including preparation of training records, training notices, collection of training materials, etc

6. Responsible for organizing and archiving employee training files;

7. Complete other tasks assigned by superiors;

Job requirements:

1. Bachelor's degree in pharmacy related majors, eligible for fresh graduates.

2. Understand the conditions and environment required for document storage, and ensure the safety of document storage;

3. Strong writing skills and supervisory execution skills in system regulations, good communication and coordination skills, service awareness, conscientious and responsible work, and a good sense of confidentiality.

Job responsibilities:

1. Responsible for the arrangement and coordination of external repair and maintenance personnel, responsible for the safety of repair, maintenance, and maintenance personnel, ensuring that no safety accidents occur and process equipment is inspected

2. Responsible for formulating maintenance plans, executing maintenance work according to the plan, and ensuring the normal operation of equipment;

3. Responsible for managing equipment spare parts and developing procurement plans d on the monthly list of required spare parts;

4. Strictly control maintenance costs, promptly keep maintenance and repair records, and classify and archive them according to regulations;

5. Participate in various technical research activities (including improving equipment reliability, rationality, energy conservation and consumption reduction), and continuously improve business level;

6. Responsible for training and safety inspection of job knowledge for new employees in the workshop;

7. Assist in the disassembly, installation, and OA repair work of departmental measuring instruments;

8. Responsible for drafting and revising GMP related documents;

9. Complete other temporary tasks assigned by superiors.

Qualification:

1. Education requirements: College degree or above;

2. Professional requirements: automation and electromechanical related majors;

3. Work experience: At least 3 years of experience in equipment operation, maintenance, and management;

4. Skill requirements: Familiar with Word, Execl, CAD and other related software.

Job responsibilities:

1. Responsible for the arrangement and coordination of external repair and maintenance personnel, responsible for the safety of repair, maintenance, and maintenance personnel, ensuring that no safety accidents occur and public equipment is inspected;

2. Develop a maintenance plan, execute maintenance work according to the plan, and ensure the normal operation of the equipment;

3. Develop a detailed procurement plan d on the required materials every month and report the plan in a timely manner;

4. Strictly control maintenance costs, promptly keep maintenance and repair records, and classify and archive them according to regulations;

5. Participate in various technical research activities (including improving equipment reliability, rationality, energy conservation and consumption reduction), and continuously improve business level;

6. Responsible for training and safety inspection of job knowledge for new employees in the workshop;

7. Assist in the disassembly, installation, and OA repair work of departmental measuring instruments;

8. Responsible for drafting and revising GMP related documents;

9. Complete other temporary tasks assigned by superiors.

Qualification:

1. Education requirements: College degree or above;

2. Professional requirements: automation and electromechanical related majors;

3. Work experience: At least 3 years of experience in equipment operation, maintenance, and management;

4. Skill requirements: Familiar with Word, Execl, CAD and other related software.

Job responsibilities:

1. Participate in the drafting of validation system documents.

2. Supervise the execution of relevant documents of the verification system.

3. Distribute validation plans, validation report numbers, validation deviation numbers, and organize and archive validation related materials according to the validation system documents.

4. Responsible for reviewing the URS of factory facilities, equipment, and systems.

5. Responsible for the confirmation and validation of factory facilities, public systems, validation instruments, and temperature equipment.

6. Responsible for the implementation of process validation and cleaning validation activities.

7. Participate in the confirmation and verification plan review of production equipment and analytical instruments, guide and supervise the implementation of verification, and review validation reports.

8. Participate in the verification of computerized systems, validation of analytical methods/validation schemes, implementation, guidance and supervision of validation, and review of validation reports.

9. Participate in the drafting and review of risk assessment reports related to validation activities.

10. Annual review of participation in validation activities.

11. Participate in the investigation and evaluation of changes and deviations in validation activities, and follow up on changes and CAPAs.

12. Complete other tasks assigned by the leader.

Qualification:

1. Education requirements: College degree or above.

2. Professional requirements: Pharmacy related majors.

3. Experience requirements: At least three years of experience in drug production and quality related work, proficient in operating validation instruments.

4. Professional knowledge: Possess knowledge of oral solid preparations, eye drops, and water injection preparations; Familiar with the implementation methods and key points of equipment confirmation, cleaning validation, and process validation; Familiar with domestic and foreign validation related regulations and guidelines, understand drug related policies and regulations, and master GMP knowledge.

Job responsibilities:

1. Responsible for the physical and chemical inspection of raw materials and finished products;

2. Responsible for ensuring that the inspection process meets GMP requirements;

3. Responsible for daily maintenance of inspection instruments;

4. Responsible for completing other tasks assigned by superiors.

Qualification:

1. College degree or above, majoring in pharmacy or chemical analysis or related fields;

2. At least 2 years of experience in laboratory analysis work;

3. Familiar with instrument operations such as HPLC, GC, IR, ICP-MS, etc;

4. Strong organization, communication and coordination ability;

5. Work diligently and responsibly, pay attention to details, and have strong hands-on skills.

Job responsibilities:

1. Responsible for the evaluation of public system equipment SIA, CCA, RA, and computerized systems, leading the drafting and upgrading of equipment operation and maintenance SOP, status identification management, and GMP confirmation work;

2. Participate in the acceptance work of various stages of public system equipment, such as FAT factory acceptance, unpacking acceptance, SAT on-site acceptance, warranty period expiration acceptance, etc;

3. Strictly follow the job SOP for operation, responsible for the operation and troubleshooting of purified water preparation system, injection water preparation system, pure steam generator, air conditioning, electric refrigeration unit, compressed air, ozone and other equipment, and keep records of equipment operation and inspection, and be responsible for archiving on a monthly basis;

4. Responsible for replacing the initial, intermediate, and efficient components, cleaning the chassis, keeping timely records, and summarizing and archiving them;

5. Responsible for implementing safety inventory management for equipment spare parts, and managing the cost of maintenance tools, consumables, and labor protection equipment for production and maintenance positions;

6. Responsible for the normal supply of public media such as water, electricity, and gas in the workshop, conducting equipment validation, review, and initiating, investigating, and handling changes and deviations to the GMP related system in the workshop;

7. Statistics and audit analysis of equipment failure rate and workshop energy consumption, reducing equipment failure rate and energy consumption through process optimization, technical transformation or system update measures;

8. Responsible for providing training on equipment structure principles, operation, and maintenance for workshop operators, supervising and guiding operators to carry out actual operations, maintenance, equipment inspection, and record filling. Responsible for the periodic work of factory related inspections;

9. Responsible for drafting and revising GMP related documents;

10. Professional knowledge training for new personnel;

11. Complete other temporary tasks assigned by superiors.

Qualification:

1. Education requirements: Technical secondary school or above;

2. Professional requirements: Chemical and electromechanical related majors;

3. Work experience: At least 2 years of experience in operation, maintenance and management of public engineering equipment;

4. Skill requirements: Familiar with Office, Word office software, and CAD drawing software.

Job responsibilities:

1. Be able to operate the Tablet press skillfully and have the ability to remove common faults; I have participated in the verification work of FAT, SAT, IQ, OQ, PQ and other related equipment for the position.

2. Able to independently draft relevant documents for this position.

3. Be able to safely and orderly complete the production tasks of the team, and ensure that all operations are carried out in accordance with relevant SOPs.

4. Standardize the filling of production records, auxiliary records, vouchers, and documents for this process, responsible for the initial review of records and timely submission.

Qualification:

1. College degree or above, major in pharmacy and mechanical engineering is preferred.

More than 2.3 years of operation experience in tablet pressing post.

3. Master commonly used office software such as Office.

4. Strong execution ability, strong sense of responsibility, honesty and dedication, strong resistance to pressure, and adaptability to overtime.

5. Familiar with the knowledge requirements related to drug GMP, have participated in the GMP certification of oral solid preparations, and have experience in FDA certification is preferred.

Job responsibilities:

1. Proficient in operating the coating machine, with the ability to troubleshoot common faults; I have participated in the verification work of FAT, SAT, IQ, OQ, PQ and other related equipment for the position.

2. Able to independently draft relevant documents for this position.

3. Able to lead team members to safely and orderly complete their production tasks, and ensure that all operations are carried out in accordance with relevant SOPs.

4. Standardize the filling of production records, auxiliary records, vouchers, and documents for this process, responsible for the initial review of records and timely submission.

5. Responsible for managing personnel and materials in this process to prevent errors and confusion.

Qualification:

1. College degree or above, major in pharmacy and mechanical engineering is preferred.

At least 2.3 years of operation experience in coating post.

3. Master commonly used office software such as Office.

4. Strong execution ability, strong sense of responsibility, honesty and dedication, strong resistance to pressure, and adaptability to overtime.

5. Familiar with the knowledge requirements related to drug GMP, have participated in the GMP certification of oral solid preparations, and have experience in FDA certification is preferred.

Job responsibilities:

1. Proficient in operating production equipment such as wet granulation, dry granulation, and fluidized bed, with the ability to troubleshoot common faults; I have participated in the verification work of FAT, SAT, IQ, OQ, PQ and other related equipment for the position.

2. Able to independently draft relevant documents for this position.

3. Able to lead team members to safely and orderly complete their production tasks, and ensure that all operations are carried out in accordance with relevant SOPs.

4. Standardize the filling of production records, auxiliary records, vouchers, and documents for this process, responsible for the initial review of records and timely submission.

5. Responsible for managing personnel and materials in this process to prevent errors and confusion.

Qualification:

1. College degree or above, major in pharmacy and mechanical engineering is preferred.

More than 2.3 years of experience in granulation operation.

3. Master commonly used office software such as Office.

4. Strong execution ability, strong sense of responsibility, honesty and dedication, strong resistance to pressure, and adaptability to overtime.

5. Familiar with the knowledge requirements related to drug GMP, have participated in the GMP certification of oral solid preparations, and have experience in FDA certification is preferred.