QA Senior Staff
QA Senior Staff
Y tế/Chăm sóc sức khỏe
10,000,000 - 13,000,000 VNĐ
- Responsible for collection, review, assessment and approval of analytical data for chemical and microbiology of finished products, stability, water, etc. analytical documents such as specifications, test methods, STP, GTP, test data sheets, etc.
- Responsible for storage of all analytical documents related.
- Responsible for co-ordination in process validation, cleaning validation, and collection, review evaluation, storage of relevant validation data and reports.
- Responsible for compliance the observations of self-inspection, including external audit within the time frame.
- This position is responsible for coordinating with other QA personels and other departments to solve the assigned works and accomplish other jobs required by QA Manager.
- Responsible for delivery-receive of production order, manufacturing instruction record, dispensing instruction record and Batch records and check the implementation of Batch records.
- Report to QA leader and is responsible for validation activity, such as prepare the related documents, monitor validation procedure
- Follow the CAPAs duration remake and GMP, GLP, GSP rules.
- Qualification of Pharmacist or other university.
- More than 3 year experiences of QA in pharmaceutical, experience in pharmaceutical manufacturing factory will be preferred.
- Experience in GMP-related issues, GLP, GSP (quality control chart, deviation and change control, internal audit, customer audit, product quality review, training).
- Carefull, honest, positive and co-operation attitude
- Ability to work in groups and manager group
- Analytical skills and scientific logic work
- Good at English or Japanese
- Professional working environment