China, Suzhou

Today lonza is a global leader in life sciences with operations on three continents。We're in science, and there's no magic formula for how to do it, right。Our best scientific solution is to bring together talent and ideas to grow our business and give back to the community。At the same time, lonza employees also get challenging career development opportunities here。Their ideas, big and small, have really contributed to the development of society。That's what we want to be a part of。

Suzhou Capsule Co., Ltd. was established in 1986 as a hollow capsule production base jointly funded by Capsugel (part of Lonza Group) and China Sinophurt Group。For more than thirty years,Suzhou Capsule adhere to the use of Capsugel advanced capsule manufacturing and testing technology,Follow the global unified quality system,Through fully automated control operation, strict indoor cleaning procedures and quality control, air temperature and humidity flow control center and other excellent production process and conditions,Always provide high quality capsule products for pharmaceutical and health products enterprises at home and abroad。

Job Description:

- Complete the routine tests of the raw materials, intermediate products and finished products, in-process samples and finished goods

- Routine microbiology laboratory management - Reagents, strains, equipment, supplies, documents, etc. Such as: the management of the equipment, the consumables, the media, the regent and the strains

- Complete the verification of daily growth promotion tests, equipment and analytical methods of culture media. And the growth promotion of the media.

-Routine microbial inspection of source, intermediate and finished products of july-source microbiological testing, in-process gel / trims and finished goods.

- Process water sampling and microbial testing. Sampling the water and complete the microbial limit testing of the city water, washer water and the purified water.

- Monitor dust particles and sedimentation bacteria in clean areas。Monitoring frequency: dust particles at least once every six months, sedimentation bacteria at least once every quarter。Monitoring must be carried out before operation after maintenance。 Periodically monitor the environment of the clean room.Airborne particles: at least once half year. Settling microbial: at least once quarterly.It must be monitored after an overhaul.

- Monthly production area compressed air use points,Monitoring water and oil content of compressed air for oil, water content, suspended particles and microorganism, particle and micro-organism in compressed air at production area.

- Perform monthly microbiological test on personnel involved directly in capsule production.

- Complete the passage of the strains every month.

- Complete the collection of microbial test data, register the collectworks, files all of the data.

- Microbiology laboratory management。Routine micro-lab management, such as equipment management, consumables management, media and reagent management, strain management, and file management. Such as: the management of the equipment, the consumables, the media, the regent and the strains.

- Actively cooperate in the investigation of microbiological related issues within the company. - Prepare product inspection report on Saturday or when necessary.

- Back-up of microbial sample collection on Saturday and other times as required.

- Draft or update job SOP. Draft and revise SOP.

- Keep working area clean and safe.

- Carry out microbial related verification with other validation methods.

- Performs all other tasks assigned by lab Supervisor in everyone's department.

- Maintain a good EHS compliant working environment and safe operation in your work or management area to ensure continuous compliance with EHS standards for capsules and local regulatory requirements

Responsible for maintaining sound EHS working conditions, practices in your assigned job or area and ensure continuous compliance to Capsugel EHS Standards and local law requirements.

- GMP Responsibility

Job Requirements:

1.1. College or bachelor degree, major in pharmacy/microbiology preferred;

2. Experience in aseptic laboratory is preferred;

3. Familiar with microbial testing methods, API, code is preferred;

4. Practical and willing to work with enthusiasm;

5. English reading and writing is a must, good oral English is preferred。

We are here at Lonza to solve complex problems and stimulate the challenge and creativity of new ideas in the life sciences。At the same time, Lonza employees get satisfaction from improving people's lives。That satisfaction comes with meaningful change。

Reference: R39645