QC 微生物检验员
海南海灵化学制药有限公司
- 公司规模:500-1000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:2016-12-09
- 工作地点:海口
- 招聘人数:1人
- 工作经验:3-4年经验
- 学历要求:本科
- 语言要求:英语 熟练
- 职位月薪:3000-4499/月
- 职位类别:生物工程/生物制药
职位描述
职位描述:
Key Tasks:
Perform sampling and routine microbiology testing, sterility testing and endotoxin testing in strict accordance with the appropriate testing methods for raw materials packaging materials, in-process and finished products.
Perform sample collection and associated routine testing for environmental monitoring program (i.e. for Water for Injection, Pure Steam, cleanroom air sampling and particle counts etc).
Perform all microbiology related testing in support of process validation and cleaning validation.
Perform microbial identification as required for routine testing and media fill procedures.
Perform stability testing to support shelf life studies for the finished product.
Develop/write and maintain Standard Operating Procedures (SOP) in the microbiology laboratory.
Perform validation of all microbiological test methods including writing protocols and reports.
Comply with Good Manufacturing Practices (GMP) and maintain strict and accurate quality control documentation of all test procedures and results.
Perform equipment calibration as required for GMP compliance.
Identify and troubleshoot equipment problems.
Ensure that lab cleanliness and safety standards are maintained.
Perform other related tasks as needed.
Qualification:
Degree in life sciences. Degree in Microbiology or recognized qualification in microbiology preferred.
3-5 years or more relevant work experience in pharmaceutical or biological manufacturing industry with good knowledge of aseptic techniques and good documentation practices.
Have working knowledge of Good Manufacturing Practices (GMPs) and be familiar with USP and EP test methodology (Microbial, Sterility, Endotoxin) for the manufacture of sterile products.
Excellent interpersonal skills, ability to work independently and in a team environment.
Efficiency with the ability to be innovative and provide creative solutions.
Strong sense of pride in ownership and quality of work.
请投递双语简历.
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Key Tasks:
Perform sampling and routine microbiology testing, sterility testing and endotoxin testing in strict accordance with the appropriate testing methods for raw materials packaging materials, in-process and finished products.
Perform sample collection and associated routine testing for environmental monitoring program (i.e. for Water for Injection, Pure Steam, cleanroom air sampling and particle counts etc).
Perform all microbiology related testing in support of process validation and cleaning validation.
Perform microbial identification as required for routine testing and media fill procedures.
Perform stability testing to support shelf life studies for the finished product.
Develop/write and maintain Standard Operating Procedures (SOP) in the microbiology laboratory.
Perform validation of all microbiological test methods including writing protocols and reports.
Comply with Good Manufacturing Practices (GMP) and maintain strict and accurate quality control documentation of all test procedures and results.
Perform equipment calibration as required for GMP compliance.
Identify and troubleshoot equipment problems.
Ensure that lab cleanliness and safety standards are maintained.
Perform other related tasks as needed.
Qualification:
Degree in life sciences. Degree in Microbiology or recognized qualification in microbiology preferred.
3-5 years or more relevant work experience in pharmaceutical or biological manufacturing industry with good knowledge of aseptic techniques and good documentation practices.
Have working knowledge of Good Manufacturing Practices (GMPs) and be familiar with USP and EP test methodology (Microbial, Sterility, Endotoxin) for the manufacture of sterile products.
Excellent interpersonal skills, ability to work independently and in a team environment.
Efficiency with the ability to be innovative and provide creative solutions.
Strong sense of pride in ownership and quality of work.
请投递双语简历.
职能类别: 生物工程/生物制药
公司介绍
海灵药业是一家集研发、生产、销售于一体的医药集团公司,自1990年在海南创办***家以化学制剂为主的药品生产企业,发展至今已近30年,旗下在香港、海南、上海、西藏等地拥有多家全资及控股子公司,员工总数近800人,资产总额近39亿元。2016年海灵药业成为长江润发集团有限公司(股票代码:002435)控股子公司,至此海灵药业实现了与资本市场的对接。
海灵药业在海南拥有2个生产基地,9条通过新版GMP认证的生产线,其中注射用拉氧头孢钠、注射用头孢他啶、奥美拉唑肠溶胶囊、注射用阿奇霉素及卢立康唑乳膏为公司的五大主要产品。
海灵药业在中国建立了完善而庞大的销售及分销网络。海灵药业通过逾600家分销商将产品销售至中国31个省、自治区及直辖市。
海灵药业本着“信誉***、质量取胜”的宗旨,将先进的质量管理体系贯彻至整个生产过程、质量控制以及新产品的研发,坚持向质量要效益,把质量管理作为重中之重。
海灵药业一直秉承“员工***”的理念,利用区域优势和卓越的产业化平台,吸引高端人才,集团各公司十分重视员工培训和综合素质的提高,厂区配套设施齐全。此外,公司积极开展丰富多彩的职工文体活动,培养职工对企业的认同感和责任感,为企业的发展注入勃勃生机。
企业的高速发展,离不开高素质的员工,海灵药业的“Grow With Hailing”和“管理培训生培养计划”旨在挖掘优秀的大学毕业生并对其进行针对性培养,同时帮助核心员工进行职业生涯规划。
海灵药业,关爱一生,欢迎广大莘莘学子的加入!
联系电话:0898-68686127/0898-68639900-1362
传真号码:0898-66792859
联系人:陈小姐
海灵药业在海南拥有2个生产基地,9条通过新版GMP认证的生产线,其中注射用拉氧头孢钠、注射用头孢他啶、奥美拉唑肠溶胶囊、注射用阿奇霉素及卢立康唑乳膏为公司的五大主要产品。
海灵药业在中国建立了完善而庞大的销售及分销网络。海灵药业通过逾600家分销商将产品销售至中国31个省、自治区及直辖市。
海灵药业本着“信誉***、质量取胜”的宗旨,将先进的质量管理体系贯彻至整个生产过程、质量控制以及新产品的研发,坚持向质量要效益,把质量管理作为重中之重。
海灵药业一直秉承“员工***”的理念,利用区域优势和卓越的产业化平台,吸引高端人才,集团各公司十分重视员工培训和综合素质的提高,厂区配套设施齐全。此外,公司积极开展丰富多彩的职工文体活动,培养职工对企业的认同感和责任感,为企业的发展注入勃勃生机。
企业的高速发展,离不开高素质的员工,海灵药业的“Grow With Hailing”和“管理培训生培养计划”旨在挖掘优秀的大学毕业生并对其进行针对性培养,同时帮助核心员工进行职业生涯规划。
海灵药业,关爱一生,欢迎广大莘莘学子的加入!
联系电话:0898-68686127/0898-68639900-1362
传真号码:0898-66792859
联系人:陈小姐
联系方式
- Email:hr@hailingpharm.com
- 公司地址:地址:span徐州
- 联系人:陈小姐