东莞招聘

职位描述：
SUMMARY
This position will be responsible for maintain/ develop the Device Quality Management System & ensure ongoing compliance to US FDA CFR 21 part 820, ISO13485, GMP, etc. and product quality marking scheme requirements as applicable. To support the site product registration /regulatory affairs support to local RA, Global RA when required and support on shelf Device quality program. In addition, responsible for quality management system of suppliers and Device contract manufacturer organizations (CMO).

SCOPE / DIMENSIONS OF ROLE

To manage, maintain and develop the Device Quality Management System to be compliance to US FDA CFR 21 part 820, ISO13485, GMP, etc. and product quality marking scheme requirements as applicable. To ensure the effectiveness of Quality programme and Quality Management System related issues in Device Business And help supporting regulatory affairs for product registration for any country market / regulatory standards required, on shelf Device quality program as well as supplier and CMO quality management system.

RESPONSIBILITIES / ACCOUNTABILITIES

General:
? To be deputy of Quality Management Representative
? To input into strategic direction (design, development and implementation of work standards & policies) to the Device Quality Function and in alignment with all condom manufacturing and healthcare care sites within RB.
? To input into the harmonisation of quality processes, procedures, documentation and specifications between condom sites and with healthcare sites (as appropriate).
? To work with, support and advise process owners to achieve efficient and compliant processes to US FDA CFR 21 part 820, ISO13485, any country GMP/regulatory requirements and product quality marking schemes as applicable
? To develop and manage the site CAPA/ Deviation (NCR) systems and support team for root cause analysis of problems
? To input into the development and maintenance of a global healthcare change management system and effective implementation at a local level.
? To establish and maintain the internal audit schedule, ensuring audits are completed in a timely manner and actions are closed out.
o To manage all external audits in plant with preparation plan, support during audit and take appropriate CAPA to ensure actions are complete within timeline
o To manage the document management system and input into strategic direction
o To manage the documentation team (support, develop, co-ordinate activities, monitor throughput)
o To monitor KPIs associated with the QMS
o To assist with and conduct where necessary as part of a pool of auditors, internal audits and supplier audits co-ordinating activities and availability of relevant staff on site. Additionally, conducting cross site audits as necessary.
o Develop and deliver internal training relating to the QMS to ensure thorough and consistent understanding of the requirements of the QMS
o To prepare reports and other supporting documentation to feed into the device (and corporate) management reviews as appropriate.
o To manage consumer complaints investigation, root cause analysis and CAPA as required.
o To collate and supply product and system information as required to support regulatory registrations.
o To ensure that quality records are maintained in line with appropriate regulations and internal policies.
o To manage site process FMEA as part of risk management system
o To be responsible for quality management system of suppliers as well as device contract manufacturers organization (CMO)
o To support any matters for product registration to any country market as well as support RA team when required
o To manage the on-shelf product quality program for monitoring the product quality issue
o Any other duties commensurate with the level and scope of the role.
o To sign on quality document / record on behalf of Quality Assurance Manager during his/her absence based on delegation/ assign

Quality:
? Be aware, accountable and follow GMP (Good Manufacturing Practice) rules & regulations
? Enforce quality mind by ‘Right first time’ practice for working in area by following documented procedures & follow good documentation practice

Safety, Health & Environment:
? Be aware, accountable for safety, health & environment in workplace all time to ensure free-accident & good environment area of working
? Follow safety, health & environment regulations & policy by working safely, reporting unsafe condition / unsafe act / near miss accident to supervisor as well as suggest for any improvement

KEY CHALLENGES

? Work under fast moving organization, standardization and improve the QMS to be more robust and compliance to relevant regulatory standards and international standards within specific and limited timeframe.
? Maintain the effectiveness of QMS under the organization having changes all time


PROFESSIONAL QUALIFICATIONS / EXPERIENCE

? QA professional with first hand knowledge and experience in US FDA CFR 21 part 820 and ISO13485 quality management systems within a medical device environment
? Clear understanding of good manufacturing practices
? Experience for auditing under ISO9001, ISO13485, ISO17025 requirements
? Knowledge and experience of International Quality standards & Marking ( ie ISO13485, ISO17025, ISO9001, Medical Device Directive, CE mark, and product marks ie.
? Experience on investigation, problem solving, data analysis, recommend corrective/preventive action
? Experience on change management program, risk analysis
? Experience on conduct supplier audit base on international standard requirements
? Degree in science based subject, ideally with additional qualification in Quality management systems
? Highly motivated self starter, flexible, proactive with excellent communication skills and the ability to influence people at all levels

PERSONAL ATTRIBUTES

? RB is a global business, opportunity to progress and relocate internationally for career development and challenge
? The business language in RB is English, therefore fluency in English is essential and fluency in local languages advantageous
? Flexible to travel, if required
? In line with RB core values, will be achievement focussed and able to work in a direct and often pressurised environment
? Entrepreneurial skills in terms of innovation and problem solving are key along with tenacity, tough-mindedness and ability to influence and demonstrate strong team working abilities and commitment as well as ethics and Integrity, flexibility and adaptability with good personality and emotion Control 举报 分享

利洁时2011年到2016年在中国增长迅速，复合年增长率达到32%。在中国上市的主要产品品牌有：滴露（Dettol）、杜蕾斯（Durex）、薇婷（Veet）、密诱（ME-U）、爽健（Scholl）、渍无踪（Vanish）、安悦嘉（Airwick）、旭福（Schiff）、慢严舒柠、咳喘宁等。2017年美赞臣的加入，使中国成为仅次于美国的利洁时全球第二大市场。

利洁时——东亚研发采购中心，成立于2003年，位于广东省东莞市，现有70多名员工。东亚采购中心隶属于英国产品研发总部，是一个负责公司各品类产品装置的研发、采购、制造及质量管控的完整供应链管理的团队，产品出口全世界。