職位描述
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
工作地點(diǎn)
甘井子區(qū)維布絡(luò)信息科技(大連)有限公司
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維布絡(luò)信息科技(大連)有限公司
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職位發(fā)布者
呂女士/HR
三日內(nèi)活躍立即溝通
維布絡(luò)信息科技(大連)有限公司WIPRO介紹維布絡(luò)公司(Wipro Limited)成立于1945年，是一家總部位于印度班加羅爾的世界著名的軟件外包公司，2000年在美國(guó)上市（WIT）。 Wipro自成立到現(xiàn)在近70年的歷史，在全世界60多個(gè)國(guó)家建有公司，雇員超過(guò)14萬(wàn)人。WIPRO在全世界各地?fù)碛谐^(guò)55個(gè)研發(fā)中心，公司根據(jù)產(chǎn)業(yè)具體需求，有超過(guò)40個(gè)方案解決中心，為全球945家企業(yè)提供服務(wù)，其中包含150+家財(cái)富500強(qiáng)企業(yè)。主要業(yè)務(wù)涵蓋了信息技術(shù)服務(wù)、信息技術(shù)產(chǎn)品研發(fā)、業(yè)務(wù)流程外包、技術(shù)工程、外部設(shè)備和客戶服務(wù)等領(lǐng)域。Wipro在紐約證券交易所掛牌上市，股票在印度孟買證券交易所和印度國(guó)民證券交易所發(fā)行。Wipro是全球最大的產(chǎn)品工程和支持服務(wù)供應(yīng)商之一。其總裁阿茲姆?普雷姆吉（Azim Premji）被譽(yù)為“印度的比爾?蓋茨”。WIPRO中國(guó)介紹WIPRO于2004年4月在上海浦東張江注冊(cè)成立了維布絡(luò)信息科技（上海）有限公司，踏出了進(jìn)軍中國(guó)市場(chǎng)的第一步；2009年7月在成都天府軟件園建立了交付中心；2010年5月同常州武進(jìn)高新技術(shù)產(chǎn)業(yè)開(kāi)發(fā)區(qū)簽訂合作協(xié)議，在常州建立了維布絡(luò)基礎(chǔ)設(shè)施工程有限公司；在東莞也建有制造中心；此外，WIPRO在深圳、北京、香港等地都建有銷售公司。WIPRO大連目前，Wipro大連坐落于大連科技生態(tài)園。大連大力開(kāi)展BPS(Business Process Service)業(yè)務(wù)，服務(wù)于亞太市場(chǎng)，并將逐步拓展開(kāi)發(fā)領(lǐng)域。維布絡(luò)大連離岸交付中心坐落于大連生態(tài)科技城，公司將配備下一代科技基礎(chǔ)設(shè)施和世界一流的培訓(xùn)設(shè)施，該設(shè)施將納入智能城市和綠色建筑設(shè)計(jì)理念。大連分公司將擁有約1000名員工,所需人才的語(yǔ)言需求將涵蓋13多種語(yǔ)言，如：英語(yǔ)、日語(yǔ)、粵語(yǔ)、越南語(yǔ)、泰語(yǔ)、馬來(lái)語(yǔ)、俄語(yǔ)、法語(yǔ)、德語(yǔ)等。公司目前及未來(lái)將提供客戶咨詢與支持、科技信息咨詢、企業(yè)管理咨詢、物流管理咨詢，及財(cái)務(wù)管理咨詢等外包服務(wù)，業(yè)務(wù)涵蓋IT、金融、汽車、零售、制造等各行業(yè)。當(dāng)前與未來(lái)將與世界知名的咨詢公司，銀行，軟件企業(yè)，制造企業(yè)等都有合作。公司辦公室將配備設(shè)施一流的培訓(xùn)室,員工休息區(qū)、健身區(qū)等配套設(shè)施,為員工提供舒適的辦公環(huán)境.郵箱：jobs-china@wipro.com
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