Trưởng Phòng QA Ngành Dược – Be (Upto $2000)Top management

1) Management and support of QA/QC department
2) Development and update of SOPs
3) Education and training of QA/QC members, analytical scientists, nurses, doctors according to ICH GCP, GLP-guidelines, in-house SOPs.
4) Communication with authorities and sponsors regarding QA/QC issues
5) Reporting directly to CEO of BE center
6) Support and respond to the audit by authorities, sponsors,..
7) Support the analytical team and clinical team in relation to QA/QC matters
8) Support for the ISO-15189, ISO-17025

More in detail
1) To perform audits of bioanalytical process and data according to in-house SOP and ICH GLP guideline.
2) To perform audits of clinical process and data according to in-house SOP and ICH GCP guideline.
3) Internal audit regularly
4) To perform QA review of analytical process, clinical process to ensure compliance with in-house SOP, GCP, GLP guidelines of ICH.
5) To prepare QA statements
6) To support or conduct vendor audit/assessment/qualification
7) To assist whenever required for regulatory inspection/sponsor audits
8) Manage the overall schedule of QA/QC audits
9) Prepare for the ISO-15189, 17025 audit
10) Good English writing and communication abilities are required.

Will be discussed in the interview.

- Attractive salary
- Opportunities to be trained in the professional environment to maximize your potential
- Good chance to study and develop career path stably

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