Specialist, Quality System
更新日期:2020-06-12
職位描述公司簡介
- Support the start-up of Quality Systems for the site.
- Execute and maintain the Quality Systems at the site.
- Document Management System
- Write, Revise, Review and Approve SOPs, protocols, reports or records.
- Conduct training
- Provide guidance on cGMP, Good Documentation Practices (GDP) and Data Integrity requirements.
- Training/Learning Management System (LMS)
- Maintenance of training curriculum/tasks.
- Custodian and archival of training records.
- Provide guidance on LMS usage.
- Trackwise System (TW)
- Provide guidance on deviation management, change control and CAPA.
- Conduct training and provide guidance on TW system usage.
- Communicate quality systems and compliance requirements effectively to peers and stakeholders.
- Provide compliance support to staff in all departments.
- Participate in regulatory, customer and internal audits.
- Any other tasks as and when assigned by the supervisor/line manager.
Key Requirements.
- Familiarity with Regulatory requirements and local Codes & Standards (e. g. , FDA, EMEA, GAMP and ICHQ7)
- Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
- Good leadership skills
- Strong interpersonal skills
- Effective Communicator (oral and written)
- Exhibit good quality decision making traits
- Meticulous and Systematic
- Analytical Mind
- Ability to define specific goals clearly, to develop and prioritize activities
- Team player, with strong focus on safety, quality and timelines
聯(lián)系方式:
公司網(wǎng)址:http://www.lonza.com.cn
公司地址:廣州市海珠區(qū)金輝路39號
聯(lián)系電話:34973888-2590
龍沙(中國)投資有限公司成立于2003年9月,是瑞士龍沙集團全資在廣州設(shè)立的投資性公司。公司旨在于醫(yī)藥、化工及生命科學領(lǐng)域進行投資和再投資,同時提供以下服務:
-協(xié)助或代理龍沙所投資企業(yè)的貨物及設(shè)備采購業(yè)務,并在國內(nèi)外市場銷售他們的產(chǎn)品;
-為龍沙所投資企業(yè)提供售后服務、技術(shù)支持及人力資源服務;
-為投資者提供咨詢服務并為龍沙的關(guān)聯(lián)公司提供市場信息、投資政策等咨詢服務。
龍沙(中國)投資有限公司
- 企業(yè)性質(zhì): 三資企業(yè)
- 業(yè)務范圍: ITO,KPO
- 所屬行業(yè):醫(yī)藥/生物工程
- 公司地址:廣州市海珠區(qū)金輝路39號
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最近瀏覽的職位
- Specialist, Quality System2020-06-12