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无工作经验 -
本科 -
招1人 -
11-09 发布
- 五险一金
- 补充医疗保险
- 免费班车
- 年终奖金
- 专业培训
- 通讯补贴
- 定期体检
职位描述
职位描述： To provide quality assurance during the release process for imported product to China market, support for relevant regulatory evaluation and submission activities, lead for imported product transfer QA release related activities, and ensure the compliance of GSK QMS, cGMP and regulatory requirements for imported product batch releaseMajor Accountabilities (Describe the 5-7 main results of the role to be achieved)主要职责内容（5-7个主要职责）- Responsible for imported product release Batch Record Summary timely preparation (including translation when necessary) with manufacture sites, including template establishment/maintenance for newly introduced imported product with external (NIFDC/SIFDC) and GSK internal stakeholders.- Ensure sample delivery to NIFDC/SIFDC timely for batch release for CMO contracted imported product with TY when applicable- Provide quality assurance oversight during product importation to ensure it align with GMP and relevant regulatory requirements- Responsible for writing and reviewing/approving of imported product APQR relevant section as related to TY if needed.- Support for imported product incident management if applicable, e.g., complaint, recall, investigation. Lead or support LIC if applicable and support PIRC if necessary- Act as product specific SPOC with NIFDC/SIFDC for technical clarifications during batch release. Required to locate in BJ/SH for certain period of time or travel more frequently at the beginning stage to build up strong positive relationship with NIFDC/SIFDC to facilitate the batch release.- Responsible for Quality Assurance Agreement (e.g., TTS, QAA) alignment with manufacture sites or LOC Quality if TY is involved as 3rd party contract laboratory or CMO (e.g., packaging)- Lead QA release relevant actions during product technical transfer from other site- Support for imported product change control GMP quality evaluations and regulatory dossier variations evaluation as requested from LRA- Ensure quality system is in place for imported product release and in compliant with cGMP, GSK QMS and relevant regulatory requirement, e.g., SOPs/SMPs, work instructions, protocols, assessment, regulatory articles, and optimize the process based on business needs accordingly- Acquire and maintain knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters is provided-- Provide support for internal/external inspection/audit related to QA release for imported product, including support for FDA inspection in imported product manufacture site if necessary.- Perform L1 inspection for QA release based on pre-defined timeline and support L2 audit for QA release.- Support for remediation and quality integration projects regarding to QA release related- Responsible for relevant PR/PO application, vendor DD if necessary- Timely escalation to management for potential risk for batch release or product incidents, and provide resolution to minimize the risk.- Promote a quality and safety culture in the workplace.- Ensure the team is operating in a cost effective and efficient manner.- Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice.Key Performance Indicators (Indicate how performance for this role will be measured)KPI绩效指标(绩效目标主要衡量指标)- Release lead time: On-time delivery of BRS and batch release related quality documents as scheduled and no delay of product importation and/or release due to quality document preparation- Product specific production/test knowledge- Right first time for BRS readiness- Quality KPIs related to product release, e.g., SOP revisions, CAPAs, change controls, deviations, product incident- Timely communication with internal and external stakeholders relevant to batch release, with no impact to product launch or routine release- Evaluate technical documents dispatched by GRA to local RA with pre-defined timeline, including but not limited to change control, variations.- Compliance of quality systems managed by QA release team-- No major/critical findings during internal/external audit for QA releaseJob Dimensions (Indicate key facts and figures)角色范围(主要关键因素)Number of associates下属人数: 0Financial responsibility财务职责: NA(Budget预算, Cost成本, Sales销售, etc.)Key business partner主要工作联络部门: QC, All QA Departments, GIO, Global Release network, Imported product Vaccines Manufacturing Sites, Global Product Life Cycle, Global CIM, Vaccines China Supply Chain and LOC Quality, RA, NIFDC, SIFDC, Project managementIdeal Background (State the preferred education and experience level)教育及工作经验相关要求Education (minimum/desirable)教育:Minimum Education:最低教育: B.S. or equivalent education, major in pharmaceutical industry related, e.g., biological, bio-chemical, chemical engineering, pharmacy, microbiology, ect.Desired Education: 有以下教育经验更佳: Education with English language background, B.S or above with education majored in pharmaceutical industry related, e.g., biological, bio-chemical, chemical engineering, pharmacy, microbiology, ect.Experience工作经验:Minimum 最低要求 :- Work in bio-pharmaceutical industry with at least 5 years experiences in process, test or quality related fields- Familiar with cGMP environment and relevant requirements for quality assurance mind-set- Good communication and leadership skills- Very good learning agility and personal development skills- International workplace experiences for technical communications or managementDesired 有以下经验更佳:- Product release or quality assurance management, process engineering or biological product analysis experiences.- Work/interact with regulatory governance- Project management with different functions even without any direct report- Familiar with international regulatory requirements regarding to batch release relatedSkills (e.g. IT)) 工作技能 (如IT技能等) ：- Good at Microsoft offices software for technical report and communication, e.g., PPT, word, excel, outlook- Technical English communication skills- Very good GMP and quality mind-set fulfilled with GSK expectations 职能类别： 药品生产/质量管理 质量管理/测试经理(QA/QC经理)
联系方式
杭州市区及周边地区
公司信息
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