Senior Regulatory Compliance Specialist 天津

月薪：

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： Job Purpose 岗位目的:To assist the RC/QMS Section Manager in ensuring site regulatory compliance to GSK & regulatory standards.To ensure registration documents for products are submitted correctly.To ensure internal audit system, QMS system effectively.Support to prepare and host L4 inspections.To ensure package standard sample checking is effective and accurate.Work with Procurement Share Service group and Supplier Quality Share Service group to ensure effective supplier quality management in GSKT site.Establish and maintain document control, archive and security system, BOM and API system, SOP training matrix system.To be TC of mylearning system of compliance training.Check and control the document system according to GMP.Key Responsibilities主要岗位职责:1.General responsibilities:?Be responsible for the preparing, reviewing, and updating of SOPs related.?Perform QMS gap analysis for relevant policies and training.?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?Trouble shooting in RC/QMS area?Perform other jobs assigned by RC/QMS Section Manager.2.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.?Conduct training related to regulations for relevant departments accordingly.?Maintain Site Master Fill System and timely updated according to relevant change.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.Recall?Maintain site recall SOP through QMS gap analysis。?Communicate with regulatory authority during recall?Archive the meeting minutes and maintain LIC and PIRC listInternal and External audit?Maintain internal auditing system, prepare annual L2 audit schedule and coordinate each L2 audit.?Maintain L1 inspection system, follow up L1 inspection adherence with each department.?Familiar with L1 inspection process, conduct L1 inspection in RC/QMS Section.?Conduct L2 inspection on schedule.?Ensure all CAPA arising from internal audit is tracked effectively.?Maintain CARISMA3 data, enter L4 report, enter findings, CAPAs of L3 and L4 audits, and follow-up and close in a timely manner.?Prepare and maintain GMP orientation training material, annual GMP training material. Deliver GMP orientation training to new staff.?Support on L3 and L4 audits.Change Control?Lead Change Control meeting and maintain Change Control systemPackage material compliance?Prepare packaging components test methods, specifications/STD.?Review artwork, standard samples.?Maintain effective specification system, maintain relevant database, make sure both hardcopy, e-version establish, distribution, archiving, retrieve, destroy fully comply with SOP, QMS and GMP requirements.Supplier management?Lead the process of Supplier Qualification in the site, working with SQ and PP to achieve this.?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.?Maintain the supplier quality KPIs and drive the improvement.?Conduct supplier performance review using material complaint analysis.?Support PP for supplier performance review.Document Control?GSKT all products related manufacturing, packaging BOM, item number, API system control, upgrade and maintain, BPCS system maintain according to approved BOM, item number, API hard copies.?Establish and implement document control system to ensure quality standard, SOPs, batch records, specification, and registration document in place.?Establish the clear document archive system, Manage Quality file centers, to make sure easily document retrieval.?Maintain the SOP system, make sure that SOP can be updated and reviewed timely, no outdated quality related documents in use.?Responsible for site information security system, lead the coordinators of each department to implement information control according to the requirement.?Responsible for document master list update and maintenance.?Be system administrator of CDMS.?Work as Record Retention Champion.Training Control?Maintain training matrix and related SOPs.?Be TC of mylearing system to coordinate site curriculum update, training record maintenance, SOP update in the system. Work as Quality department training plan tracer.?Archive training record by people by security method.?Deliver the training of document quality SOP to employee.Specialized Knowledge 专业知识:?breadth & depth across disciplines or functions; expertise in field required所需知识的宽度（跨学科），所需知识的深度 （特定学科）ESSENTIAL?University graduate or higher in appropriate pharmacy or relative fields.?Minimum 3 years experience in regulatory affairs function in pharmaceutical industry.?Be familiar with cGMP and regulatory requirements in supplied markets (e.g. China, SEA, Latin America, UK, Europe).?Technical knowledge on pharmaceutical production and quality.?Ability to work and solve problem independently.?Meticulous & careful with details?Good communication skills.?Auditing skills.?Good English oral and writing skills.? Ability to add value to the business.?Master Computer Ms office software including word, excel and so on.DESIRED?Good interpersonal skills. 职能类别： 药品生产/质量管理

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公司信息

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、最现代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，成为中国目前规模最大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。

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