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Job responsibilities:

Responsible for the confirmation, maintenance, maintenance and daily management of HPLC, GC, atomic absorption, ultraviolet, infrared and other related precision instruments in the analytical laboratory.

Responsible for computerized system management such as alarm processing and authority configuration of related workstations such as Epower software or CDS software.

Qualifications: 

Have 3 years or more of rich experience in the confirmation, maintenance, maintenance and daily management of related precision instruments such as HPLC, GC, atomic absorption, ultraviolet, infrared, etc., and have 3 years or more of alarm processing in related workstations such as Epower software or CDS software. Computerized system management experience such as authority configuration. Preference is given to engineers with EU or FDA certification experience and after-sales maintenance experience in large companies such as Agilent or Waters.

Job responsibilities:

1. Carry out various equipment management work in an orderly manner, effectively improve equipment preventive maintenance work, effectively improve equipment utilization and reduce equipment failure rate;

2. Responsible for the effective operation of the safety system in the production workshop;

3. Responsible for team management, organization of business training, and improvement of equipment personnel, post personnel management and operating equipment technical level;

4. Responsible for guiding and supervising the development and implementation of preventive maintenance, repairs, training, technical transformation, and technical research of equipment teams;

5. Responsible for the implementation, inspection, improvement and improvement of equipment management related documents (equipment management, operation, maintenance SOP, computerized system SOP).

Qualifications: 

1. Have more than 5 years of equipment management experience;

2. Experience in passing EU and FDA international projects;

3. Familiar with equipment principles and GMP management concepts of pharmaceutical companies;

4. Familiar with the business content of various directions of equipment management in pharmaceutical enterprises, and have experience in basic equipment operation, maintenance, repair and equipment confirmation;

5. Understand the company's production formulation process, product key quality attributes and key process parameters.

6. Majors related to electromechanical and electrical automation, majors related to medicine

Job responsibilities:

1. Responsible for internal and external product transfer project management, and formulate the company's annual technology transfer project plan.

2. Participate in the early technical exchanges of product technology transfer, take the lead in organizing the company's technology transfer project coordination meeting; coordinate and follow up the implementation progress of various departments, and maintain and update the product technology transfer project plan, and coordinate to solve the problems of the project in charge;

3. Responsible for the collection of relevant data in the early stage of the company's technology transfer, formulating/reviewing relevant changes, risk assessment, CQA and CPP assessment, process verification, process regulations, batch production records and other related documents;

4. Responsible for formulating the process verification, continuous process confirmation, and cleaning verification plan for the marketed products, training, tracking and technical guidance on the verification process, handling technical problems in the verification process, and reporting the verification results;

5. Participate in the quality and technical research and improvement of the company's listed products to ensure product quality is safe and effective.

Qualifications:

1. Familiar with laws, guidelines, and industry standards related to verification at home and abroad

2. Familiar with the process of equipment, public systems, cleaning verification, and process verification

3. Three years of relevant verification experience in verifying solid preparations

4. Familiar with regulations and guidelines related to cleaning verification and process verification at home and abroad, and can independently complete cleaning verification and process verification plan writing

5. Familiar with ICQ9, and be able to use risk analysis tools proficiently in the pre-evaluation of cleaning verification, CQA and CPP evaluation.

6. Have EU or FDA certification experience.

7. Proficiency in English listening, speaking, reading and writing.

8. Knowledge of statistics is preferred.

9. Personnel with solid preparation production experience is preferred.