QC Microbiological Team leader
- Work location
- Room A708, Building 1, No.600 Huaxi Road, Minhang District, Shanghai
- Job type
- Management position
- Job responsibilities
- 1. Responsible for the management and staff training of the microbiological testing team.
2. Ensure safe operation of microbiology laboratory and comply with GMP management.
3. Responsible for the drafting and revision of SOP, verification scheme and inspection records of microbial inspection items related to the company's project products.
4. Responsible for drafting and revising SOP, verification scheme and records related to environmental monitoring
5. Responsible for calibration and confirmation of inspection equipment related to microbial testing.
6. Responsible for the use and management of testing reagents, consumables, strains, utensils, etc.
7. Guide the investigation of deviations and OOS/OOT in the inspection process, and write the investigation report.
8. Participate and support production process verification, cleaning verification and environmental monitoring as required.
9. Complete the testing task as planned, and communicate with superiors about problems in time. Maintain good communication with other QC lab teams.
- Qualification
- 1. Bachelor degree or above in pharmacy or microbiology.
2. At least 3 years of microbiology work experience (at least 1 year of sterile drug testing experience), at least 1 year of microbiology team leader or supervisor management experience.
Strong ability to work under pressure, clear thinking, proficient in GMP and other regulatory requirements of microbiology laboratory.