Responsibilities:
1.Prepare for regulatory audit and company level audit, issue relevant corrective and key in CARISMA system.  Follow up commitment and make it close on time.
2.In charge of the regulatory filing, communication and compliance follow up.
3.Approve and monitor all quality related systems, procedures and documentation utilised within production streams.
4.Ensure any changes have been appropriately validated and documented in accordance with approved TSKF processes.
5.Push the QMS compliance progress, organize the gap analysis and action tracking in the site, including the risk assessment and management.
6.Issue periodical internal audit plan, ensure finish task on time.  Follow up corrective action and make it close on time.  Approval/reject supplier/third party according to audit results and their performance.
7.Coordinate the change control, customer complaint and track the action, ensure production processes comply with registration detail.
8.Coordinate the TTS approval and on time refresh.
9.Review all change controls in TSKF.

Qualifications：
1.Bachelor, Pharmacy or related.
2.Familiar with relevant National and local quality regulation.( GMP, GSP, SFDA, IDC).
3.More than 6 years experiences, 4 years management experiences in Quality area at least.
4.Familiar with report system/measurement system/Audit system.
5.English level CET-6 for oral and reading ability.
6.High ability of communication, coordination, leading and creation.