Resident Specialist
Negotiable
Minimum Education:
Junior College
Number of Recruits:
1
Experience requirements:
1-3 years
Work area:
Lixia District, Jinan City, Shandong Province
Job Responsibilities:
1. Responsible for on-site monitoring and necessary sampling during the production process (mainly raw materials, solid preparations, and injection dosage forms).
2. Responsible for the audit of production records and inspection records of commissioned production batches, and responsible for the investigation of abnormalities, deviations and changes in the process of commissioned production and inspection, and the implementation and follow-up of processing opinions.
3. Responsible for the verification and reconfirmation of production equipment and other equipment and instruments of the company (including program review and implementation follow-up).
4. Participate in the audit of the technical documents of the entrusted production enterprise, and the audit of the annual product quality review of the entrusted production enterprise.
5. Participate in the auditing of all material suppliers of the company and the preparation and revision of the company's quality system documents.
6. Participate in the management of the company's stability reserved samples.
7. Participate in the guarantee of the company's quality system, regularly spot check the company's internal quality situation and report in writing.
8. Experience in quality assurance related to MAH is preferred;
9. Complete the tasks assigned by the superior.
Qualifications:
1. College degree or above in pharmacy, pharmaceutical engineering and other related majors; able to operate computers and office software proficiently;
2. More than 2-3 years of experience in production or quality management in pharmaceutical companies;
3. Familiar with the drug management law, GMP regulations and product production processes (injections, solid preparations); have the ability to make correct judgments and handle practical problems in quality management;
4. Possess strong coordination, communication, learning and adaptability, strong written expression ability and logical thinking ability;
5. Strong principle, rigorous work, serious and responsible, proactive;
6. Can bear hardships and adapt to frequent business trips;
Job benefits: five insurances and one housing fund, flexible work, no overtime, regular team building, weekend weekends, employee travel
Address: Room 2602, Huiyuan Building, 38 Huaneng Road, Lixia District, Jinan City, Shandong Province
©Shandong Yumankun Biotechnology Co., Ltd.