On-site QA Job Responsibilities
Job requirements
Job requirements and conditions
On-site QA Job Responsibilities
No limit
full-time
Negotiable
Job Description
1. Responsible for quality supervision of each batch of drug production and inspection process; communicate with CMO in time for tracking and rectification of problems found during inspection;
2. Participate in dealing with deviations, changes, returns, etc. during the production process;
3. Audit product process protocols, batch production records (blank), process/cleaning validation programs and reports;
4. Audit batch production records, batch inspection records, complete product release audit, batch file archiving;
5. Participate in CMO, material supplier site quality audit;
6. Draft quality agreements for commissioned production of pharmaceutical products, check the design of printed packaging materials and other text content information;
7. Responsible for product annual quality review report data collection and audit;
8. Participate in the collection and audit of B license additions; participate in GMP compliance checks.
Qualifications
1. Bachelor degree or above in pharmacy related majors;
2. 2 years and above working experience in sterile preparation, engaged in QA or production management related work;
3. Familiar with drug administration law, drug production supervision and management methods, GMP, MAH related laws and regulations;
4. Adapt to business trip, work conscientiously and responsibly, and be good at communication with the outside.
Seefunge Pharmaceutical Technology Co., Ltd.
Address: BioPharma Town, Hangzhou City, Zhejiang Province, China