400-885-9898
职位描述
QMSGCPGVPISO3485
· 12 - 13 years (10+years)
·as Qualified Safety implementation manager at a global/domestic pharmaceutical companies OR
·as clinical staff at a pharmaceutical company OR
·as an auditor QMS/GCP/GVP audit at CRO
Roles and Responsibilities
·as Qualified Safety implementation manager at a global/domestic pharmaceutical companies OR
·as clinical staff at a pharmaceutical company OR
·as an auditor QMS/GCP/GVP audit at CRO
Roles and Responsibilities
- Thorough understanding of the Japan Medical Device Regulations, MAH GVP requirements. What MAH must do before and after finalizing the GVP
agreements between the vendor and the MAH - Familiarity with the Japanese Pharmaceuticals and Medical Devices Act (PMD Act) and other related regulations.
- To keep the Quality Management System (QMS) updated and compliant with
internal guidelines and global standards with regards to the scope and
points mentioned by you in trailing mail. - Domestic PMS activities including reporting to regulatory authorities
- Assist with internal and external audits to ensure adherence to respective
standards and regulations - Manage controlled QMS documentation including SOPs, manuals, and procedures
- Investigate product issues such as complaints and non-conformances, and determine appropriate corrective actions or reporting
- Prior experience with QMS implementation and knowledge of Ordinance No.169 and ISO 13485
- Work closely with MAH and distributor/cross functional teams.
- Set up the QMS - Call handling process, Complaint handling process, RCA – CAPA management
- Perform mock audits for Audit readiness
- Participate and anchor all planned and unplanned customer and regulatory audits
- Any support required in submission
- The QA Safety Implementation Manager also
- Reviews all complaint for Japan to
ensure all potential health injuries have been flagged. - Ensures planning and dissemination
of GVP related training in the vendor - Ensure planning, execution of annual
GVP self-inspection and CAPA implementation if needed. - Day to day tasks
- Receive a list (EXCEL file) of the information registered as complaints in Compliance Quest the previous day from an operations team and review the contents. If a Potential Adverse Event (PAE) is included, record it in the list.
- Regardless of whether a PAE is found or not, send the list to the customer’s Japan Safety Manager as review record (every business day).
- If the operations team has overlooked the occurrence of a PAE and forgotten to flag it as a PAE in Compliance Quest, provide feedback to the operations team
- Participating in Business Review meetings required by SQA
- Have discussion based on KPIs
- Plan GVP training and ensure the dissemination.
- Plan GVP self-inspection and ensure the execution. Report the self-inspection results to 3 MAHs (NOVA, Asahi etc.).
- Be involved in CAPA discussion for Nonconformance (NC) according to the vendor’s SOP if the NC is a safety matter.
- Participate in supplier audit by the MAHs as auditees
- In Summary
- Overseeing PV activities performed by Wipro, in this case the collection and processing in CQ of the complaints and PAEs
- Ensuring that the activities they perform comply with GVP and their SOPs/WIs comply, including self-inspection and record management.
- Be involved in any audits by regulators or MAHs
- Train staff at Wipro that are dealing with Japan in GVP
- Co-ordinate with customer and the other MAHs
工作地点
甘井子区维布络信息科技(大连)有限公司
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维布络信息科技(大连)有限公司WIPRO介绍维布络公司(Wipro Limited)成立于1945年，是一家总部位于印度班加罗尔的世界著名的软件外包公司，2000年在美国上市（WIT）。 Wipro自成立到现在近70年的历史，在全世界60多个国家建有公司，雇员超过14万人。WIPRO在全世界各地拥有超过55个研发中心，公司根据产业具体需求，有超过40个方案解决中心，为全球945家企业提供服务，其中包含150+家财富500强企业。主要业务涵盖了信息技术服务、信息技术产品研发、业务流程外包、技术工程、外部设备和客户服务等领域。Wipro在纽约证券交易所挂牌上市，股票在印度孟买证券交易所和印度国民证券交易所发行。Wipro是全球最大的产品工程和支持服务供应商之一。其总裁阿兹姆•普雷姆吉（Azim Premji）被誉为“印度的比尔•盖茨”。WIPRO中国介绍WIPRO于2004年4月在上海浦东张江注册成立了维布络信息科技（上海）有限公司，踏出了进军中国市场的第一步；2009年7月在成都天府软件园建立了交付中心；2010年5月同常州武进高新技术产业开发区签订合作协议，在常州建立了维布络基础设施工程有限公司；在东莞也建有制造中心；此外，WIPRO在深圳、北京、香港等地都建有销售公司。WIPRO大连目前，Wipro大连坐落于大连科技生态园。大连大力开展BPS(Business Process Service)业务，服务于亚太市场，并将逐步拓展开发领域。维布络大连离岸交付中心坐落于大连生态科技城，公司将配备下一代科技基础设施和世界一流的培训设施，该设施将纳入智能城市和绿色建筑设计理念。大连分公司将拥有约1000名员工,所需人才的语言需求将涵盖13多种语言，如：英语、日语、粤语、越南语、泰语、马来语、俄语、法语、德语等。公司目前及未来将提供客户咨询与支持、科技信息咨询、企业管理咨询、物流管理咨询，及财务管理咨询等外包服务，业务涵盖IT、金融、汽车、零售、制造等各行业。当前与未来将与世界知名的咨询公司，银行，软件企业，制造企业等都有合作。公司办公室将配备设施一流的培训室,员工休息区、健身区等配套设施,为员工提供舒适的办公环境.邮箱：jobs-china@wipro.com
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