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
?Review/approval qualification & validation document and facilitating qualification & validation execution of technical equipment qualifications / device qualifications / computerized system validations /method validations / cleaning validations / process validations within the Quality Management System (QMS) Asia Manufacturing Site (AMS) on the basis of regulatory standards.
?Qualification & validation technical expert in at least two or three aspects mentioned above, such as equipment qualification, device qualification and computerized system validation etc.
?Performance of periodic reviews of qualifications/validations according to written procedures and tracking of agreed-upon actions. Sustained maintenance dedicated tool.
?Control and archiving of SOPs/standards and evidence documents according to regulatory requirements.
Main Tasks & Responsibilities主要工作职责 :
1.Quality Assurance (QA) 质量保证工作– 85%
1.1Qualifications are planned and checked / released in accordance with the specifications,
1.2The qualification and validation activities are carried out together with the specialist departments in accordance with the specifications as well as being processed in due time and documented,
1.3Provide consultancy to all functional units regard to qualification/validation queries and support the qualification/validation implementation.
1.4Concepts for the qualification of systems and equipment are described and implemented jointly with the responsible site functions,
1.5The valid state is maintained due to the control and follow-up of periodic reviews.
2.Employee Leadership 员工领导力– 15%
2.1Skilled in thinking interdisciplinary; creating confident and open relationships within all organizational levels, specifically within matrix organizations
2.2Set some of his/her own goals and tasks after discussions with superior
2.3Deal with complex problems in diverse range of tasks
2.4Master the responsibility for the accomplishment of the business strategy and goals, moderate effects on
several departments or interests (customers, staff and environment)
Education& Qualifications教育背景与专业资格:
?University graduate in of the following fields: pharmacy, pharmaceutical engineering, (bio-)chemistry, (molecular)biology, and/or biotechnology;
Experience工作经验:
?Experienced in the field of process equipment / utility (water system, HVAC etc.) / laboratory equipment qualification or process / cleaning / computerized system validation (3-5 yrs.) in pharmaceutical or diagnostic industry
?Some experience and proven skills in coordination different parties under complicated environment
Leadership Competencies领导能力:
Leadership competencies at basic level, in line with corporate framework.
参照罗氏集团领导能力标准和要求,领导能力达到基本水平。
Professional Competencies/skills专业能力/技能:
?Basic knowledge relevant regulations and industry standards, such as ISO 13485, IVDD, GMP, GAMP
?Basic knowledge regarding the qualification and validation
?Proficient language skills (written and spoken) in Chinese and English
?Competent with routine application of MS Office and other common office software, incl. databases
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