Professional：

Master the professional knowledge of equipment, HVAC, pure water, air pressure, steam, construction, electrical automatic control, master the requirements of GMP regulations, and be familiar with the requirements of ISPE

Job description:

1. Organize the daily operation, maintenance, repair and transformation of plant and facilities, equipment and systems;

2. Organization and coordination of new and renovation projects, such as project design, contractor selection, construction management, project acceptance, etc.;

3. Organize the research, design, purchase, installation, debugging and confirmation of equipment; provide technical support for newly purchased equipment in QC, logistics and other departments;

4. The presentation and implementation of the department's annual budget.

Professional：

Pharmacy or pharmacy-related major, more than 3 years of analytical work experience in a pharmaceutical factory

Job description:

1. Perform various inspections in accordance with the requirements of the GMP quality management system, laboratory management SOPs, and work instructions to ensure the timeliness of the inspections and the accuracy of the results.

2. Responsible for the testing of purified water, raw materials, intermediate products, finished products, stability samples, clean area environment and compressed air.

3. Responsible for the truthful, timely, accurate and complete filling of inspection records and GMP auxiliary records.

4. Carry out daily maintenance on the instrument and keep it in good operating condition;

5. Timely report of laboratory abnormal events, OOS/OOT, deviations, and laboratory investigations.

Professional：

Pharmacy, chemistry, machinery related majors, more than 5 years of relevant work experience in pharmaceutical factory verification, familiar with verification of plant facilities and equipment, verification of computerized systems, cleaning verification, etc.

Job description:

1. Responsible for the management of verification and confirmation, to ensure that verification and confirmation meet cGMP requirements;

2. The establishment and maintenance of the verification system, the drafting of the verification manual and the factory's verification master plan;

3. Verify the drafting and review of the master plan;

4. Review of verification documents and records;

5. Establish and maintain a template for verification documents;

6. Computerized system verification, cleaning verification and risk assessment, process verification, quality risk management, verification-related deviation and change assessment and management, equipment and facilities authority sorting, system periodic review and reconfirmation management.