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QualityAssuranceManager

岗位类别: 生物化工/制药工程   专业要求: 不限  
学    历: 本科  工作经验: 3 年
工作地区: 上海市  月    薪: 面议 
性别要求: 不限  招聘人数: 1 人 
发布日期: 2008-7-4  人才网站: 前程无忧 
        

QualityAssuranceManager职位说明及要求



Requirements:
Education: B.S. in biological, medical or chemical science
Experience: 3 years of QA experience. Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.
Personality: Mature, open and team player.
Skills:
Good English (verbal and written) skills
Comfortable with speaking in public
Knowledge of FDA regulations, and familiarity with OECD (European) and MWH (Japan) regulations are extremely desirable. At minimum, some experience in a GLP or GMP compliant organization is necessary.
Knowledge of routine analytical methodologies
Detail oriented and able to deal with multiple and changing priorities.
Ability to work under minimal supervision. Interactions with supervisor are primarily to inform the supervisor of activities
Demonstrate proficiency with regulation and guideline interpretation, audit procedures, proper documentation and QA departmental policies and procedures

Responsibilities:
Consults with QA VP regarding priority of assignment
Reviews complex projects and must be able to evaluate compliance with special client criteria
Audits laboratory data for compliance with methods and standard operating procedures and report findings
Audits sample result tables and analytical reports for completeness and accurate representation of the data and report findings
Conducts project specific inspections of laboratory procedures to evaluate compliance with analytical methods and standard operating procedures and report findings.
Client and inspector interaction
Conducts general facility inspections as assigned
Conducts audits of vendors and subcontractors as assigned
Evaluates audit and inspection findings and consults with QA VP regarding appropriate course of action and reporting requirements
Identifies issues which may require follow-up inspection and consult with QA VP for scheduling follow-up inspection
Provides training for new staff

Job Responsibilities:
The QA Manager assures the quality of laboratory data and reports. This is accomplished by audits of data and reports as specified by Standard Operating Procedures and by conducting inspections of laboratory procedures and laboratory personnel’s qualifications.

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澎立生物医药技术(上海)有限公司地址和其它联系方式
公司地址:上海伽利略路, 388号, 7号楼
邮政编码:200135
电子邮箱:Careers@pharmalegacy.com
公司网址:

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