1. Ensure
the fully compliance of site manufacturing, laboratory process with current GMP
regulation, Sanofi global quality guildline or registration dossier, including responsibility
but not extrausted below:

-
Production, lab area oversight,
and related CAPA follow up;

- Review
of SOP and batch production/test record;

-
Deviation handling, supervise the investigation process
and CAPA definition;

- Fully invovled
change control evaluation, self-inspection and quality plan activities.

2. Maintain
site validation valid condition of facility, equipment and process, to ensure
the compliance with current GMP regulation, Sanofi global quality guildline,
including responsibiity but not extrausted below:

-
Review validation protocol/report. Provide technical support
and supervision during the execution.

-
Site validation activities
follow up to maintain the fluent running of site VMP;

-
Responsible for the establishing
of site validation strategy SOP;

3. Organize
the drafting and approval of the anually product review report, EM and clean
utility retrospective report.

4. Responsible
for the cold
chain data management.

5. Take
part in the construction and maintenance of Site Quality Culture.

6. Any
other works as assigned by line manager.