JOIN US
JOIN US
Microbiological Testing Supervisor [Quality Department]
Negotiable
Education:
不限
|
Work experience:
3-5年
|
Number of recruits:
1
Job description
1. Carry out the corresponding work according to the company's organizational structure. Supervise and formulate corresponding job responsibilities and training plans.
2. Complete the work content of microbiology. Oversee the maintenance of laboratory buildings and facilities.
3. Responsible for supervising the formulation of cleaning and disinfection procedures, temperature and humidity management procedures, and supervising the drafting and review of URS for equipment and facilities.
4. Responsible for supervising the drafting and implementation of equipment use or decommissioning and maintenance documents, formulating the preparation of stability test management documents and the inspection of stability tests.
5. Responsible for supervising and formulating the scientific sampling process of materials and packaging materials, formulate sample retention management regulations, and conduct scientific sample retention work and inspection.
6. Supervise and formulate inspection procedures and quality standards for water system and gas system, raw materials, auxiliary materials, packaging materials and finished products, and inspect according to the process.
7. Supervise the inventory of reagent consumables and the formulation of procurement requirements, as well as the sorting and archiving of laboratory data.
8. Complete the formulation and implementation of standard product management and supervise personnel to conduct experiments in accordance with SOP regulations.
1. More than 3 years of work experience, with laboratory management experience and microbiological inspection experience in pharmaceutical companies (chemical drugs, vaccines, biopharmaceuticals, etc.);
2. Have relevant working experience in the laboratory of injections/APIs/tablets, familiar with relevant regulations and be able to identify regulatory compliance risks;
3. Familiar with relevant national laws and regulations on drug management
4. The values are in line with the company, and have good execution, team building, interpersonal communication and organizational coordination ability, plan management ability, learning ability and communication ability;
5. Possess the ability to search and identify literature and materials, and be able to collect sufficient evidence for an in-depth analysis and judgment on a certain issue.
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