QC分析员-QC Analyst
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:
MAJOR AREAS OF RESPONSIBILITY
Documenting and reporting results in accordance with GMP and GLP.
Providing technical support to your peers.
Participate in method validation protocol and reports in a timely manner with accuracy and precision in compliance with laboratory SOPs, product specifications, and regulatory guidelines.
Participate in method development and method validation/verification for API and finished products.
Participate in the resolution of issues with respect to laboratory analysis and laboratory instrumentation.
Providing technical support within and outside the department.
Performing all work in accordance with all established regulatory, compliance and safety requirements.
Training junior analysts as requiredMaintaining professional relationship with internal/external departments.
Conducting investigation of unexpected issues in developmental and regular products as directed and provides solutions to resolve the findings
Revising and updating existing methods when required
Performing tests for Certification of Analysis of Raw Material, Finished Products and Stability Samples within assigned time period
Maintaining accurate and complete records
Participating in the development and/or providing recommendations for department SOPs and procedures
Assists in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GLP
All other duties as assigned
EDUCATION/COMPETENCIES REQUIREMENTS
Education: Master or Bachelor in Science, major in Chemistry
Experience: Minimum of 3 years Quality Control experience in the Pharmaceutical industry
Specialized Training: Good knowledge and understanding of GMP, GLP, analytical techniques and method validation.
Sound theoretical and technical knowledge of chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, LC-MS, AA, TOC, etc.
Sound understanding of current GMP, ICH and FDA requirements
Ability to manage multiple projects and tasks concurrently and effectivelyAbility to meet deadlines and prioritize tasks with strong attention to detail
Excellent organizational skills to meet frequent changes in immediate priorities, problem solving skills, and understanding of various computer software programs required
Excellent computer proficiency with MS Office programsWilling to work in a team-based environment
Ability to work with limited direct supervisionSuperior interpersonal skills
Ability to analyze data
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MAJOR AREAS OF RESPONSIBILITY
Documenting and reporting results in accordance with GMP and GLP.
Providing technical support to your peers.
Participate in method validation protocol and reports in a timely manner with accuracy and precision in compliance with laboratory SOPs, product specifications, and regulatory guidelines.
Participate in method development and method validation/verification for API and finished products.
Participate in the resolution of issues with respect to laboratory analysis and laboratory instrumentation.
Providing technical support within and outside the department.
Performing all work in accordance with all established regulatory, compliance and safety requirements.
Training junior analysts as requiredMaintaining professional relationship with internal/external departments.
Conducting investigation of unexpected issues in developmental and regular products as directed and provides solutions to resolve the findings
Revising and updating existing methods when required
Performing tests for Certification of Analysis of Raw Material, Finished Products and Stability Samples within assigned time period
Maintaining accurate and complete records
Participating in the development and/or providing recommendations for department SOPs and procedures
Assists in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GLP
All other duties as assigned
EDUCATION/COMPETENCIES REQUIREMENTS
Education: Master or Bachelor in Science, major in Chemistry
Experience: Minimum of 3 years Quality Control experience in the Pharmaceutical industry
Specialized Training: Good knowledge and understanding of GMP, GLP, analytical techniques and method validation.
Sound theoretical and technical knowledge of chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, LC-MS, AA, TOC, etc.
Sound understanding of current GMP, ICH and FDA requirements
Ability to manage multiple projects and tasks concurrently and effectivelyAbility to meet deadlines and prioritize tasks with strong attention to detail
Excellent organizational skills to meet frequent changes in immediate priorities, problem solving skills, and understanding of various computer software programs required
Excellent computer proficiency with MS Office programsWilling to work in a team-based environment
Ability to work with limited direct supervisionSuperior interpersonal skills
Ability to analyze data
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