上海招聘

Key Responsibilities:
? Be responsible for the preparing, reviewing, and updating of SOPs related.
? Perform QMS gap analysis for relevant policies and deployment the QMS requirements in site.
? Trouble shooting in RC/QMS area.
? To assist RC Section Manger to notify authorizes of regulatory related issue.
? Maintain China QP system to comply with China regulation.
? Assist Head of Quality to organize Quality council.
? Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures.
? Internal & External Audit related
? Supplier management
? Perform other jobs assigned by RC Section Manager.
Specific responsibilities:
Regulatory Compliance
? Prepare product registration dossier and samples.
? Support NPI team to prepare new product introduction required submission dossier.
? Prepare application document for changing manufacturing certificate for new product addition.
? Maintain new/updated regulation follow up process and ensure the appropriate gap analysis is conducted.
? Archiving and maintaining registration dossier related to the site.
? Conjunction with GMS Regulatory Affairs Department to establish the China regulations information database in ensuring site regulatory compliance to China regulatory standards.
? Maintain site quality regulatory intelligence to generate initial assessment, identify risk and response timely.
? Generate initial regulatory advice to support other function and conduct training related to regulations for relevant departments accordingly.
? Maintain Site Master File System and timely updated according to relevant change.
? Support PPR for RC related activities.
? Lead the process of customer complaint investigation and ensure customer complaint report complete timely.
Supplier management
? Lead the process of Supplier Qualification in the site, working with SQ and PP to achieve supplier profile timely.
? Supplier change management. Follow site change control process to get the change initiated, follow up and close. Working with SQ and PP to get necessary support.
? Communicates with suppliers ensuring they understand site quality requirements.
? Lead the process of supplier complaint investigation and ensure supplier complaint report complete timely.
QMS
? Support to maintain QMS implementation system at GSKT, circulate QMS release information and track gap analysis.
? Ensure all CAPA arising from QMS gap analysis is tracked effectively.
? Prepare and maintain GMP orientation training material, annual GMP training material. Deliver GMP orientation training to new staff.
Product Incident and Recall
? To assist RC Section Manager to maintain product incident SOP through QMS gap analysis.
? Archive the meeting minutes and maintain LIC and PIRC list.
Internal audit
? Maintain internal auditing system, prepare annual IBM inspection schedule, and coordinate each IBM audit.
? Maintain MM inspection system, lead every department to complete MM inspection schedule, and follow up MM inspection adherence with each department.
? Familiar with MM inspection process, conduct MM inspection in RC Section.
? Follow up IBM inspection on schedule.
? Ensure all CAPA arising from internal audit is tracked effectively.
? Support RC section manager to prepare GSK global audit, and set up inspection readiness plan, follow up CAPA closure.
External audit
? To assist RC Section Manager to prepare for external audit, set up inspection readiness plan.
? Maintain VQMS data, enter Regulatory Inspection report, enter findings, CAPAs of A&A and Regulatory Inspection audits, and follow-up and close in a timely manner.

Change Control
? Lead Change Control panel meeting and maintain Change Control system as system owner.
? Support management team review Change Control KPI and lead the change control system improvement in GSKT site.
? Support on change risk management
KPI and Quality Risk Model
? Support site leadership to generate data for quality risk model and follow up.
? Support management team review quality KPI and follow up the system improvement in site.
Education Background:
? Bachelor’s degree and above in physical science, Pharmacy, Biology, Chemistry or related field
? Fluent in written and spoken English.
Professional Experience：
? Minimum 3 years of experience in quality/GMP field, at least 1 years in related quality compliance area

葛兰素史克公司在中国的历史最早可追溯至20世纪初叶。自20世纪80年代以来，在中国政府改革开放政策的感召下，公司在中国积极投资，将最先进的制药技术、最优质的产品、最新型的商业模式、***化的管理理念和市场营销技巧引入了中国。
葛兰素威康和史克必成公司于2000年12月完成全球性合并，2002年，葛兰素史克(中国)投资有限公司全面完成业务整合并正式宣布成立，成为中国目前规模***的跨国制药企业之一。公司业务由处方药、非处方药、疫苗和消费保健品4大部分组成，投资公司和地区总部位于北京，主要业务中心分设在上海、天津和香港。
葛兰素史克是最早在中国成功兴建合资企业的外国制药公司之一。在进入中国的20多年间，葛兰素史克先后成立了5家公司，目前2家为合资企业，总注册资本超过2.3亿美元。目前公司在全国28个主要城市(包括香港)设立了办事机构，在全国拥有近3000名员工，为中国的医药行业培养了一大批高素质的商业管理人员和技术骨干。