Software Specialist
科文斯医药研发(上海)有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2020-11-23
- 工作地点:上海-浦东新区
- 招聘人数:若干人
- 工作经验:2年经验
- 学历要求:本科
- 职位月薪:0.8-1.6万/月
- 职位类别:化学分析测试员 医疗器械维修人员
职位描述
The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job.
I. Job Summary:
Familiar with lab software and software shanghai site qualification. Work with team complete the software related work. Must familiar with instrument and equipment IQ/OQ/PQ’s SOP and could complete software qualification by following guide or SOP.
Duties and Responsibilities:
¨ Following Guide and/or SOP complete software site qualification or validation.
¨ Maintains instrument/equipment qualification documentation and software validation records.
¨ Independently sets-up, maintains, operates and performs routine and non-routine maintenance on general equipment, including problem identification and resolution.
¨ Performs quality control review of instrument logbook.
¨ Informs software administrator, PI and manager the instrument maintenance deviation that may affect integrity of the data; participates in corrective action of problems.
¨ Promotes a cohesive team environment.
¨ With supervisory assistance, assures technical staff compliance to SOPs and other regulatory agency guidelines.
¨ Work with team complete the Eworkbook template create.
¨ Performs annual year review for Watson, Analyst, Eworkbook,softmax and other software.
¨ With supervisory assistance, serves as a lead chemist on projects, overseeing a small group of technical staff.
¨ Trains, mentors, and assists less experienced staff.
¨ Participates in new equipment and instrument assessment and qualification, as appropriate.
¨ Participates in client visits as needed, assists in communicating software and equipment information.
¨ Participates in process improvement initiatives.
¨ Writes SOPs and guide.
¨ Performs other related duties as assigned.
Required:
¨ Minimum Bachelor of Science/Arts (BS/BA) degree in chemistry or related scientific field
¨ Experience may be substituted for education.
¨ Ability to perform advanced computer skills (e.g., Word, Excel).
Required:
¨ 3 years related or relevant laboratory experience required with a BS/BA degree or 1 to 2 years’ experience with an MS degree.
¨ Familiar with use of standard laboratory software (e.g., Watson, Analyst, Eworkbook, Softmax).
¨ Familiar with the use of standard laboratory equipment (e.g., balances, pipettes, centrifuges).
¨ Experience with use and trouble shooting of analytical equipment.
¨ Effective communication (verbal and written), presentation and interpersonal skills.
¨ Work with the global team and do a true reflection of the problems encountered.
¨ Advanced time management skills to complete project assignments on time, with minimal or no supervision.
¨ Able to effectively schedule resources.
¨ Understands and helps staff with compliance to SOPs and other regulatory agency guidelines.
¨ Identifies process improvement opportunities, recommends solutions and implements action plans.
¨ Able to effectively communicate, both verbally and in writing.
¨ Effectively interacts with internal and/or external software team.
¨ Knowledgeable on a variety of study types, analysis procedures and methodologies.
Location: 上海市浦东新区周浦康新公路3377号(免费班车)
公司介绍
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联系方式
- Email:yuanxin.fang@covance.com
- 公司地址:地址:span浦东新区伽利略路338号9号楼