长沙招聘

职位描述：

SUMMARY

Reporting to the R&D Quality Manager this role is responsible for the management and oversight of the Quality Management System (QMS) in the R&D facility locally in line with current regulatory requirements and internal RB standards and requirements. The role may lead a team of R&D Quality Associate(s) supporting routine Quality Management System activities on the site depending on the activities conducted on that site.

RESPONSIBILITIES / ACCOUNTABILITIES

· Ensures that the local Quality Management System meets current regulatory requirements and RB internal standards as defined within the RB Business Management System (BMS)

· Ensures RB policies are implemented within local SOPs within the local QMS as appropriate

· Ensures that there is an appropriate and systematic approach in place for the quality approval of documents such as batch manufacturing records, Standard Operating Procedures, deviations, change controls, risk evaluation and management documents, validation documents and other quality related records as defined within the local QMS

· Develops and manages an annual internal audit program for the site to verify and improve the effectiveness of the of the operational quality management system

· Ensures that there is a system in place that manages the assessment, audit and approval of external GMP suppliers and service providers used during the development process

· Maintains an approved supplier list for the facility locally or as part of a global system and ensures Technical Agreements are in place and are reviewed as per internal RB requirements

· Maintains and communicates performance of the QMS via the agreed Quality Key Performance Indicators – to ensure deviation, change controls and out of specifications are handled to a high standard in appropriate timeframes

· Schedules and leads the Management review for the site

· Manages the quality release function for the site supporting Clinical Trials (Hull only)

· Manages the quality release function supporting Consumer trials locally and as appropriate. Ensures that the systems that in place locally are aligned with the R&D quality release systems in Hull.

· Manages the annual GMP quality improvement action plan for the facility and ensures quality improvement initiatives are assessed and implemented promptly and effectively

· Ensures a system is in place to deliver GMP Induction and refresher training and that training on key quality systems and principles is also provided to the R&D Teams locally

· With the R&D Category Teams, ensures that the technical transfer of projects are completed and consistent with satisfactory handover to manufacturing and launch to the market

· Provides quality input and approval of software validation, including major systems impacting R&D

· Ensures that key quality documents are kept up to date for example Site Master File, IMP Manufacturing Authorisation as appropriate

· Responsible for the development of his/her team members to enable them to achieve their full potential

· Proactively monitors and ensures the facility has plans in place to respond to changes in guidance and legislation issued by Regulatory Authorities

· Leads the preparation for and actions arising from inspections by Regulatory Authorities/Notified Bodies

KEY CHALLENGES

· Maintains a balance of personally managing aspects of the QMS while delegating activities to the wider team where applicable

· Requires a level of international travel to support the assessment of international suppliers

· Ensures staff in R&D are adequately trained in quality and compliance systems and procedures

· Ensure that suppliers of services, raw materials and components to R&D meet GMP and R&D standards.

· Manages resource allocation and prioritisation within the team as appropriate

· Building an environment and culture that supports the core values and which enables development of key talent

· Development and maintenance of “leading edge” quality management systems in alignment with best practice in Supply and Global Quality Assurance.

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

· Interacts cross functionally to ensure seamless launch of NPD and EPD

PROFESSIONAL QUALIFICATIONS/ EXPERIENCE

· Degree in a relevant scientific discipline e.g. Pharmacy, Biology or Chemistry

· Qualified or in training to be an EU QP, eligible to assess and release IMPs for Clinical studies – UK based role requirement

· Trained and experienced Lead Auditor

· Minimum of 5 years’ experience within Healthcare/FMCG multidisciplinary environment

· Pharmaceutical sector quality system design and implementation experience including OTC/Monograph drug, Medical Device and Computer System Validation

· Broad knowledge of regulatory requirements at an international level

· Intimate understanding of the product life cycle including R&D, Manufacture and Distribution

· Experience with recruitment, management and development of people

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

· Good leadership, motivational and interpersonal skills

· 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

· 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