中美天津史克制药有限公司(中美史克)<br>Regulatory Compliance Specialist 质量部法规符合专员<br>Responsibilities:<BR>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. <BR>2.In charge of the regulatory filing, communication and compliance follow up. <BR>3.Approve and monitor all quality related systems, procedures and documentation utilised within production streams. <BR>4.Ensure any changes have been appropriately validated and documented in accordance with approved TSKF processes. <BR>5.Push the QMS compliance progress, organize the gap analysis and action tracking in the site, including the risk assessment and management. <BR>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. <BR>7.Coordinate the change control, customer complaint and track the action, ensure production processes comply with registration detail. <BR>8.Coordinate the TTS approval and on time refresh. <BR>9.Review all change controls in TSKF.
<BR>Qualifications:<BR>1.Bachelor, Pharmacy or related. <BR>2.Familiar with relevant National and local quality regulation.( GMP, GSP, SFDA, IDC). <BR>3.More than 6 years experiences, 4 years management experiences in Quality area at least. <BR>4.Familiar with report system/measurement system/Audit system. <BR>5.English level CET-6 for oral and reading ability. <BR>6.High ability of communication, coordination, leading and creation.不限
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