安阳招聘

职位描述：

SUMMARY

The purpose of this position is to ensure that the quality management system is functioning to a high standard, is performance monitored and improved and that through cross functional working with the wider R&D Team ensures compliance of the R&D Healthcare Quality Management System to internal and external GxP standards.

Whilst partnering with the wider R&D Teams supports the review and approval of quality management system documentation including deviations, change controls, SOPs, batch manufacturing records (BMRs) and sample release.

Manages the third party vendor approval system and conducts audits both internally and externally.

Assists in the preparation for, and management of, regulatory body inspections.

SCOPE / DIMENSIONS OF ROLE

The scope of the role will occasionally require guidance and demands great flexibility and appreciation of the R&D QMS and product launch activities on a global scale.

The role will deliver quality specific training to the local R&D Team, needs to be capable of supporting and enabling product launch activities whilst partnering cross functionally and needs to realise the internal and external audit schedule on an annual basis.

The role is subjected to changes in external standards and guidelines. This requires proactive coordination across all R&D categories and functions to ensure current regulatory expectations are being adhered to.

The role will require travel to RB Manufacturing and R&D sites and 3^rd party vendors as part of the support the role provides to the business.

R&D are subjected to at least 2 major inspections or audits per year from an external regulatory body in which the role will be required to coordinate a cross functional team to support and achieve a successful outcome.

RESPONSIBILITIES / ACCOUNTABILITIES

· Ensures that the Quality Management System complies to current GXP standards and internal RB requirements

· Ensures compliance of the local QMS with the RB Business Management System at the local site level

· Implements the annual internal and external audit schedule, conducts audits, provides suggestions for improvement and monitors completion of CAPA actions

· Is responsible for the coordination and publishing of the defined Quality Management System metrics(KPIS) locally on a monthly basis and ensures that they are systematically communicated to the R&D Team

· Monitors internal compliance trends to identify areas of improvement and working with the R&D Team enables key improvement initiatives are identified and implemented

· Approval and improvement of GMP related SOPs, Batch Manufacturing Records and validation documents

· Review and Approval of change control, deviations and out of specification records

· Provides Training to RB staff on – GMP and GCP Induction, delivers Annual GMP Refresher training and other specific quality related training in line with the standards defined in the QMS

· Links with Global Quality Compliance and Supply QA to maintain alignment and best practices to Global standards

· Prepares for, and takes an active part in managing inspections by regulatory authorities and internal RB audits

· Monitors and manages performance to CAPA resulting form regulatory inspections

· Provides quality input into development projects at an operational level enabling progress and improvements that realise product launch

· Proactively monitors and responds to changes in guidance and legislation issued by Regulatory Authorities.

KEY CHALLENGES

· Proactively monitoring and implementing changes to the local QMS

· Maintaining a balanced compliance culture while delivering the business needs- partnering with the local R&D Teams where everyone takes ownership for quality is essential to the success of this role

· Works with Category Teams on projects to ensure timelines are met in line with current regulatory and internal standards

· Ensures QMS metrics are systematically published and proactively improved using excellent communication tools.

· Participates in the local Management review programme

· Comfortable evaluating and implementing risk evaluation and management activities is a significant part of the role

· Development and maintenance of “leading edge” quality management systems in alignment with best practice

· Maintain awareness of broad activities of R&D, Marketing and Supply, integrating quality systems as required for product regulatory compliance

· Interacting cross functionally to ensure a “seamless” product launch

PROFESSIONAL QUALIFICATIONS/ EXPERIENCE

· Good degree in a relevant scientific discipline

· Lead Auditor trained

· 6+ years experience within Healthcare/FMCG multidisciplinary environment

· Quality system design, implementation and monitoring experience

· Previous experience of using Quality System tools such as Trackwise

· Very broad knowledge of regulatory requirements at an international level

· Understanding of the activities of R&D and a broad understanding of the product life cycle

· Results oriented, entrepreneurial and self-motivated, with solid planning and organisational capabilities, a bias for action, and the capability to define, evaluate and take risks

· Global mindset, commercial understanding of corporate and operational business issues

· Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action

· Excellent communication skills, both written and oral

· Proven ability to work under pressure without compromising on deliverables

· Understanding of strategy and planning issues, consumer understanding, priority setting and project management

· Capable of building strong working relationships and motivating teams to deliver outstanding results with or without hierarchical relationships

· Commercial understanding of corporate and operational business issues

Working Location: Qingdao, Shandong, China

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利洁时是全球500强企业，是全球最大的家用清洁及个人护理消费品公司之一，总部位于英国伦敦。在60个国家运作高品质的家用清洁用品、个人护理用品和药品，产品行销180个国家和地区。我们的历史可以追溯到18世纪：在英国生产面粉的Reckitt和在德国生产工业化学原料的Benckiser。1888年开始，我们已经开始在伦敦股票交易所上市，通过合资，以及有选择性的并购，我们已经成为富时指数前25位的全球性公司。
利洁时在中国的发展一直以生产和推广高品质的家庭清洁和个人卫生护理用品、推动中国健康护理事业的发展目标。作为蜚声国际的跨国企业，利洁时在中国市场生产和销售高质量的知名品牌家庭清洁产品。
开发极具潜力的市场，始终是利洁时公司投资的核心战略之一。1995年利洁时来到中国，在广州成立了第一家合资企业-利高曼（广州）有限公司，1996年与湖北活力28集团合资组建了湖北活力美洁时洗涤用品有限公司，从此扎根荆州，开始了利洁时投资中国市场的历程。随着中国国际地位的提升，在加大投资及完成中国区域资源整合的同时，利洁时更坚定了在中国投资的信心。2006年，在中国成立了利洁时家化（中国）有限公司（利洁时全球全资子公司）。为了使中国区的工厂真正成为国际生产基地，几年来利洁时在中国的投资势头不减，在组织结构调整和人员配备方面更是格外重视。2010年随着利洁时全球收购了SSL集团，利洁时在中国增加了新的产品品牌，工厂以及团队。

目前利洁时中国的品牌有：
Dettol （滴露）
Veet （薇婷）
Finish （亮碟）
Airwick (安悦嘉）
Dosia （巧手）
Durex （杜蕾斯）
Scholl （爽健）
Vanish（渍无踪）
我们以我们自己在这个高度竞争的全球市场中创造的成绩而骄傲，并深刻意识到我们的成功是直接和我们善于接受挑战，充满热情和才华的员工联系在一起的。
想要了解我们更多的历史和信息，请参阅公司网站 www.rb.com