Overall purpose of Job 1.Responsible for the quality of, and meeting the applicable requirements for, the assigned products that company markets and/or the products under company which take responsibility by company CQ team and quality system maintenance. 2.Responsible for compliance with the elements of the company Quality Policy that are applicable to the GxP activities company undertakes. 3.Supporting China PMF Consistency Check Project and MAH annual report project. 4.Other assigned CQ activities.

Key responsibilities China PMF Consistency Check Project - Collaborate with cross function team timely complete the consistency check based on the PMF plan. - Follow up the defined action plan with project. - Support constantly improvement of PMF consistency check process and procedure. Quality System: - Maintenance and implementation of the Quality System via transposition of the applicable requirements (laws, regulations and the elements of the COMPANY quality policy, standards and procedures etc.) as are described in the Commercial Quality Manual (CQM). - Drive continuous improvement of the Quality System & processes using quality system performance information, in conjunction with information from periodic internal audits, deviation management, CAPA management etc. - Drives temporary / short term workforces as are assigned by the managers. Regulatory Compliance: - Ensure that company marketed products, packaging components, labelling meet the local regulatory requirements. - Support implementation of the regulatory standards management standard and procedures. Document, data and Change Controls: - Prepare, update applicable LOC procedures. - Responsible for assigned product change controls and ensure appropriate internal and external change control procedures are followed Quality System/Regulatory Compliance/ Product Life-Cycle Management Inspection Management: - Preparation, execution and follow up for external inspections for responsible areas. Escalation of Quality and Regulatory Compliance issues: - Notify and engage LOC Head of Commercial Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures outlined in Commercial Quality Manual (CQM). Internal Audit management: - Conduct assigned (self-)inspections of GxP practices that are applicable for all regulated functions under company. Events and Deviation Management: - Ensure that all events and deviations for company products and critical systems are suitably, scientifically and logically handled, documented, investigated for route cause and assessed for its impact on product quality and safety. - Ensure appropriate corrective actions and preventive Actions (CAPA) are taken to mitigate the effect of an event / deviation as well as to prevent recurrence in the future. New Product Launch and Product Life-Cycle Management: - Support the LOC management team in new product introduction and all other product portfolio lifecycle management processes. Support for Quality Complaint Management Support for MAH annual report project. Required Qualification and Core Competencies 1.A bachelor’s degree major in chemistry, pharmaceutics, biology, or a related life-science discipline. A master’s degree or above is preferable. 2.Minimum of 2 years’ experience in a multinational pharmaceutical company, relevant working experience to regulatory, compliance and vaccine is preferable. 3.Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release, and distribution processes. 4.Have knowledge of relevant pharmaceutical regulations and GxP. 5.Excellent communication skills, including ability to effectively communicate with internal and external customers; good computer skill; good presentation skill. Proficiency in verbal and written English.