招聘人数:1-2人
到岗时间:不限
年龄要求:不限
婚况要求:婚姻状况
语言要求:
英语
Job Summary职位概述:
Ensure deviation, change control and CAPA system in RDSZ meets the regulatory (ISO13485, China GMP, FDA 21 CFR 820 etc.) requirements and the requirements from Divisional Quality Standard.
The requirements are implemented effectively and elements of the identified areas in RDSZ quality management systems are continuously improved.
The relevant quality assurance principles, e.g. concerning AURORA (Saleforce) case handling.
Be backup as the relevant quality assurance principles, e.g. concerning product release, change control, deviation reporting, CAPA are implemented.
Electronic Quality tools are used and maintained (e.g. AURORA (Saleforce) and a trending of important Quality Metrics is carried out.
Main Tasks & Responsibilities主要工作职责 :
1.Supply Chain Claim (Saleforce Case) Management – 50%
1.1Review and release of claim in Saleforce;
1.2Coordination of Supply Chain Claim is handled in accordance with system requirement;
1.3Management on training and authorization of Saleforce system for AMS
2.Support on Change Management – 20%
2.1 Establishment and safeguarding of the local change board at AMS as to ensure compliance with internal (Roche Policies, Divisional Quality Standards) and external requirements (ISO 13485, IVDD, GMP, CFDA and AISA countries’ specific regulatory if applicable) within Operations and other QM-relevant processes.
2.2 Be interface with RPD change board for critical changes based on definition. Sitting in RPD change board as representative of AMS QA.
2.3 Take the lead of change control IT tools (UniteD) RDSZ roll up, implementation and maintenance
3.Support on Deviation and CAPA Management – 20%
3.1 Review and release of event, OOS and deviation reports are carried out in accordance with the specifications.
3.2 Coordination of CAPA cases is done in accordance with the specifications.
3.4 Review and release of CAPA cases are carried out in accordance with the specifications.
3.5 Any product problems are managed in accordance with the specifications.
3.6 Participate in product problem meetings (for the product portfolio) so that – in the event of product problems complaints – the respective CAPAs (corrective and preventive actions) are defined as well as being processed with the appropriate priority and implemented in due time, including a criticality assessment and possible
3.7 The legal requirements of the QMS are complied with during the implementation of the CAPA actions,
amongst other things by means of a Q-review before the completion of CAPAs and a Q-review of quality
notifications that are prepared in the course of CAPAs / product problems / complaints. In the event of
deviations, there is to be an escalation to the responsible decision-making committees
4.Batch Record Review and Product Release – 10%
4.1 As backup, support Batch Record Review and Product Release tasks.
Education& Qualifications教育背景与专业资格:
Detailed understanding of the common processes in production and R&D as well as general business practices within the regulated field of diagnostics and/or pharmaceuticals.
Education& Qualifications教育背景与专业资格:
University graduate (MSc) in one of the following fields: pharmacy, (bio-)chemistry, (molecular)biology, food and/or biotechnology; ph.D. optional.
Experience工作经验:
Well experienced in the field of development and implementation of QM / QA processes (5-10 yrs.)
Long-term experience(above 2 years) and proven skills in leading employees via successful leadership strategies, implementation of processes and structures, including motivation and individual development of employees together with the implementation of restructuring processes
Leadership Competencies领导能力:
Leadership competencies at proficient level, in line with corporate framework.
参照罗氏集团领导能力标准和要求,领导能力达到熟练水平
Have good experiences in dealing with peers/stakeholders in global culture diversity environment.
Good in conflict management and stakeholder management.
Good communication skills, including communication capability with people from different countries,
different industries, as well as interface experts from global functions.
Mutual team player.
Have capability to make the balanced decision, ensure both quality/compliance requirements as well
as business needs are met in responsible area.
Professional Competencies/skills专业能力/技能:
Familiar with relevant regulatory statutes and industry standards, such as ISO 13485, IVDD, GMP, CFDA Experienced with the principles and system processes / tools within the QA/QM field
Experienced in dealing with all level of authorities including China FDA officers, TUV auditors, Korea FDA officers, etc.
Experienced in analysis of QA/QM processes, particularly with respect to compliance, efficiency and effectiveness
Professional QM-auditor with specific certification / degree
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