QA

Nanjing

1

2022-08-31

Job responsibilities: 1. Be responsible for formulating quality related management procedures and establishing and improving the quality management system according to the national guidelines and policies on drug quality management. 2. Be responsible for the quality management of the company, implement the laws and regulations on drug research and development, production, inspection and sales, and supervise and inspect the internal implementation of the company to ensure compliance with the requirements of laws and regulations. 3. Be responsible for the management of quality related documents of the company 4. Organize written / on-site audit of suppliers, summarize audit data, and establish, maintain and keep supplier files. 5. Organize the GMP / GLP / GSP on-site inspection or quality audit of the entrusted production enterprises, entrusted inspection / research institutions or qualified drug trading enterprises, and be responsible for the maintenance and safekeeping of the archives of the entrusted production enterprises and inspection institutions. 6. Be responsible for the company's product recall, annual quality review, annual report, return and other related work, as well as the storage of the generated data and files. 7. Be responsible for reviewing the process procedures, operating procedures, verification schemes / reports, product stability investigation schemes / reports, quality standards, etc. of all products of the company, including the documents and materials related to the products drafted and revised by the entrusted manufacturer. 8. Recheck and confirm the batch production / packaging records and batch inspection records of all entrusted products, including all records of material inspection, intermediate product inspection, finished product inspection, deviation or change, inspection abnormality, etc. 9. Be responsible for drafting the quality agreement for entrusted production of drugs, and participate in the supervision and inspection of the entrusted production and inspection process of products, timely point out the non-compliance with GMP requirements found in the process, and urge the entrusted enterprise to complete the rectification. 10. Participate in the supervision and inspection of product transfer, process verification, cleaning verification and other verification processes. 11. Participate in the deviation, abnormal conditions in the inspection process, OOS / OOT, relevant contents of changes, and the storage of the generated data. 12. Participate in the investigation of product complaints and the implementation of rectification measures, and track the completion. 13. Organize self inspection, including the implementation of the company's quality assurance system, the integrity and traceability of the original records, and the entrusted production enterprises. Report the inspection results to all departments, formulate improvement measures, and supervise the implementation of improvement measures. 14. Participate in product return, treatment of nonconforming products, adverse drug reactions, pharmacovigilance and other related work. 15. Review the text content of the printed packaging materials of the company's products before printing. 16. Ensure that each batch of products on the market has completed the corresponding inspection, necessary review and release, and that appropriate measures are taken to ensure the drug quality during the storage, shipment and subsequent operations of the products. 17. Supervise the establishment and management of personnel files, the formulation and implementation of the company's training plan, and the management of employee training files. 18. Other work related to product quality and quality assurance system of the company.

Job requirements: 1. College degree or above in pharmacy, chemical engineering or related majors; Familiar with drug management law and GMP requirements; Have received professional knowledge training related to API and preparation products. 2. Have good communication and coordination ability and team spirit, and work conscientiously and responsibly; It can make correct judgment and treatment to the actual problems in the process of drug production; Be able to adhere to the principle and be proficient in operating computer and office software.

Workshop process technician

Nanjing

1

2022-08-31

Job responsibilities: 1. Be responsible for the management of product process technology of the company. 2. Be responsible for the process verification of the company's products in the entrusted enterprise. 3. Inspection of batch orders, batch production records and batch packaging records in the production process of the company's products. 4. Collection, review and summary of the company's product batch file data. 5. Review of the company's product process procedures, verification schemes and other data. 6. Supervision and inspection of the production process of the company's products. 7. Work related to deviation investigation and change control. 8. Manage and coordinate the company's product molds. 9. Product transfer, process verification, cleaning verification and other verification processes.

Job requirements: 1. College degree or above in pharmacy, chemical engineering or related majors; Familiar with drug management law and GMP requirements; Have received professional knowledge training related to API and preparation products. 2. Have good communication and coordination ability and team spirit, and work conscientiously and responsibly; It can make correct judgment and treatment to the actual problems in the process of drug production; Be able to adhere to the principle and be proficient in operating computer and office software.

Pharmacovigilance specialist

Nanjing

1

2022-08-31

Job responsibilities: 1. Collection, disposal and report of adverse drug reaction information; 2. And evaluate drug risks, put forward risk management suggestions, organize or participate in risk control, risk communication and other activities; 3. Write the master document of pharmacovigilance system, regular safety update report, pharmacovigilance plan, etc; 4. Or participate in the post marketing safety study of drugs; 5. Or assist in the communication, education and training related to pharmacovigilance; 6. Work related to pharmacovigilance.

Job requirements: 1. Have medical, pharmaceutical, epidemiological or related professional background, be familiar with the relevant laws and regulations and technical guidelines of pharmacovigilance in China, and have the knowledge and skills of pharmacovigilance. 2. Good communication and coordination skills and teamwork spirit, and serious and responsible work; Be able to adhere to the principle and be proficient in operating computer and office software.