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GMP Compliance Specialist, Shanghai Pharmaceutical industry 16709/LUCY | [查看更多类似职位] |
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工作地点 |
上海 |
发布日期 |
2008-06-02 |
工作年限 |
5年经验 |
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薪水范围 |
面议 | 学历要求 | 本科 |
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| 职位描述 |
职位类别： 生物/制药/医疗器械 工作地点： 上海 发布日期： 2008-05-05 工作经验： 5-10年 最低学历： 本科 管理经验： 否 工作性质： 全职 招聘人数： 1人 职位描述/要求： Operationally reports to : Compliance Manager Key working relationships Internal Frequent contact with related functions under GMP control at Wuxi Supply Point Frequent contact with related functions at Marketing company for GXP control External Frequent contact with GCMG or global QA/DMG or other Quality function Frequent contact with SFDA at all levels Frequent contact with regulatory authority Job Purpose v To establish and sustain a culture of regulatory compliance at Wuxi Supply Point that is proactive and professional that meets regulatory requirements, adds value and delivers a competitive advantage to the business. Job Responsibilities Catch up and review the current regulatory requirements and make assessment, including: v China/EU/FDA GMP or guidelines v Q/C Manual v GCMG strategies v Global QA/DMG strategies etc. Develop compliance improvement plan Monitor the implementation Annual compliance assessment report v Make out annual internal audit plan v Develop internal audit system and to ensure its implementation v Follow-up corrective actions and document archiving Coordinate external GMP inspections to ensure no critical deficiencies v Develop vendor assurance system and to ensure its implementation v Make out annual vendor audit plan Coordinate vendor audit and document archiving v Establish and maintain good relationship with SFDA and regulatory authority for business needs Job requirements University graduate, major in pharmaceutical or related subjects Good GMP and quality system management knowledge, and pharmaceutical knowledge 5 years of Working experience on Pharmaceutical company 2 years of multinational working experience Good English&Good Computer skill Good communication skills, strong quality minds and strong service minds Competencies Sets a highly ambitious, clearly prioritized vision for the team; provide clear direction and define priorities for the team; listen to the different voices and win the commitment of team members v Key actions: communicate the importance of the vision and values, facilitate the people to react, challenges the status quo; leads change. Adapting approach to gain the commitment and delivering to objectives v Key actions: challenges and empowers others to achieve their full potential, creates a climate of empowerment and commitment through trust and personal integrity Continuously invest time and effort to gain new skills and knowledge required to succeed in the work v Key actions: shows exceptional ability to learn quickly from different job experiences and adapts quickly to new assignments, always eager for new experiences within and outside area of interest/expertise. Inspire, motivate and develop people to achieve the organization’s goals v Key actions: passionate about the recruitment and retention of talented people, creates quality development opportunities for top talent; ensures superior performance is recognized and rewarded, give people opportunity and latitude to take responsibility and achieve results; delegate significant accountability and provide the necessary support and resources for success, accurately identify strengths and development needs in others; give honest and constructive feedback; provide challenging assignments to facilitate individual development Show strong willingness to work closely with peers within and outside the team toward a common goal v Key actions: build trust by respecting the ideas&contributions of all team members; share information, knowledge&ideas with team members, provides assistance&support to other team members when needed; cooperates across organizational boundaries to ensure customer satisfaction, participate, accept and support the team’s decision, praise and encourage people appropriately. 联系方式： To submit your application, in strict confidence, please apply to lucy.xiong@hudson.com quoting Ref number 16709/Lucy, or you can contact with her on +8621 2321 7830. Your interest will be treated in the strictest of confidence. .
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