验证专员Validation Specialist
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
- 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:
PRINCIPAL DUTIES AND RESPONSIBLITIES:
Oversees all IQ, OQ, PQ, Sterilization, Cleaning and Process Validation activities. Manages requalification and revalidation program to ensure a continued state of compliance.
Provides direction, feedback and guidance to validation specialists and technicians. Writes validation protocols, including Master Plans; determines required validation testing based on guidelines (FDA).
Audits and approves protocols, drafts and executed reports.
Assesses process and equipment designs and writes pre-validation studies.
Tracks, maintains & investigates (or designates an investigator) for validation deviations.
Designs and improves validation systems and SOPs.
Supervises the work of third-party resources needed for the completion of validation projects, when required.
QUALIFICATIONS:
Degree in Engineering (Biochemical, Chemical, or Mechanical), Physical or Life Sciences.
Minimum of 3 years Validation experience in a pharmaceutical environment.
Sterile product experience, including both aseptic and terminally sterilized parenterals strongly preferred.
Management or supervisory experience is preferred.
Proficiency in Microsoft Office applications including MS Project.
请投递双语简历。
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PRINCIPAL DUTIES AND RESPONSIBLITIES:
Oversees all IQ, OQ, PQ, Sterilization, Cleaning and Process Validation activities. Manages requalification and revalidation program to ensure a continued state of compliance.
Provides direction, feedback and guidance to validation specialists and technicians. Writes validation protocols, including Master Plans; determines required validation testing based on guidelines (FDA).
Audits and approves protocols, drafts and executed reports.
Assesses process and equipment designs and writes pre-validation studies.
Tracks, maintains & investigates (or designates an investigator) for validation deviations.
Designs and improves validation systems and SOPs.
Supervises the work of third-party resources needed for the completion of validation projects, when required.
QUALIFICATIONS:
Degree in Engineering (Biochemical, Chemical, or Mechanical), Physical or Life Sciences.
Minimum of 3 years Validation experience in a pharmaceutical environment.
Sterile product experience, including both aseptic and terminally sterilized parenterals strongly preferred.
Management or supervisory experience is preferred.
Proficiency in Microsoft Office applications including MS Project.
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