QC Supervisor (Microbiological Lab)
默克投资（中国）有限公司
- 公司规模：10000人以上
- 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：2017-11-06
- 工作地点：南通
- 工作经验：无工作经验
- 职位月薪：1-1.5万/月
- 职位类别：药品生产/质量管理 质量管理/测试主管(QA/QC主管)
职位描述
职位描述：
DETAILS OF POSITION
Job Title QC Supervisor (Microbiological Lab) Grade: 10
Reporting to Quality Control Manager
Dotted Line Function Quality
Division/BU Merck Life Science Quality
Place of work Nantong, Jiangsu
SPECIFIC JOB DESCRIPTION
Purpose of the job (State in one sentence the overall objective of the job)
? This role is responsible for supervising quality control microbiological group to achieve excellence in analytical areas through competent and capable staff and suitable equipment, technologies and procedures and to support NMCC products lifecycle approach.
? Provide support for laboratory running such as management of reagents, reference standards, Instrument Routine Maintenance, HSE, documentation (SOP / Work Instruction / testing monograph / primary record, etc) and other activities in microbiological lab.
Key Accountabilities (Describe the 6-8 main results of the job to be achieved)
? Lead/Supervise laboratory tests (e.g. Bacterial endotoxins, Sterility test, Fertility test, water system tests, environment monitoring, Cell Culture etc.) through operating standard and specialized laboratory equipment in accordance with SOPs, working instructions procedures and testing monographs, and document properly in a timely manner.
? Be able to identify the critical points for microbiological management.
? Perform lab equipment qualification, method transfer and validation.
? Problem solving for analytical equipment and processes.
? Contribute to problem solving associated with laboratory work such as OOE/OOS investigation.
? Maintain high level of safety, environmental protection and housekeeping in all laboratory operations, comply to relevant Quality System cGMP requirement. Contribute also in the system establishment.
? Take responsibilities in assigned projects as appropriate.
? Be a valuable team member of Quality organization and develop self and others (e.g. junior lab staff/new comer training) through close teamwork and cross functional/sectional activities. Be a continuous improver.
Key Performance Indicators (Indicate how performance will be measured)
An accurate suppliers list is maintained and updated on a periodic basis, posted, and archived.
? The number and severity of cGMP observations identified during internal and external audits.
? Testing of products according to agreed delivery times.
? No safety incidents.
Job Dimensions (Indicate key facts and figures)
Number of Staff: 1 Direct: Indirect: 4-5
Financial responsibility: microbiological cost control
(Budget, Cost, Sales, etc.)
Impact on the organization: Internal: n.a. External: n.a.
CANDIDATE’S PROFILE
Background (State the preferred education, qualification and experience level)
? College or University level. (Microbiology, Biochemistry, Pharmaceutical etc.)
? Attainment of qualified/responsible person status under local/international legislative requirements
? Local language, English speaking, reading and understanding
? At least 5 years of Microbiological test/supervision experience in QC lab from Vaccine manufactory, Drug Product manufactory. Physical and chemical tests experience and SAP system operation will add value.
? Cross-functional working environment
? Has experience of internal and external inspections
Job specific Competencies & Skills (Describe the skills, personal abilities and behaviours that are required for the effective performance of this job)
？ Skilful in using office application software (MS-Word, MS-Excel, MS-Outlook)
？ Be able to work independently. Coach junior employee to perform
the analysis work within cGMP environment and minimize labora-tory errors
？ Challenges ’status-quo’
？ Inter-cultural competence
？ Opportunities
？ Overseas training in EU.
？ Lead a group of technicians in microbiological lab.
？ Extent knowledge in microbiological lab (CCM&RTU).
？ Flexible working time.
？ Different career opportunities in quality department in future e.g. pro-motion, job rotation opportunities within QC (Micro lab to PIS lab) or across QA/QC to build systematic quality concept.
DETAILS OF POSITION
Job Title QC Supervisor (Microbiological Lab) Grade: 10
Reporting to Quality Control Manager
Dotted Line Function Quality
Division/BU Merck Life Science Quality
Place of work Nantong, Jiangsu
SPECIFIC JOB DESCRIPTION
Purpose of the job (State in one sentence the overall objective of the job)
? This role is responsible for supervising quality control microbiological group to achieve excellence in analytical areas through competent and capable staff and suitable equipment, technologies and procedures and to support NMCC products lifecycle approach.
? Provide support for laboratory running such as management of reagents, reference standards, Instrument Routine Maintenance, HSE, documentation (SOP / Work Instruction / testing monograph / primary record, etc) and other activities in microbiological lab.
Key Accountabilities (Describe the 6-8 main results of the job to be achieved)
? Lead/Supervise laboratory tests (e.g. Bacterial endotoxins, Sterility test, Fertility test, water system tests, environment monitoring, Cell Culture etc.) through operating standard and specialized laboratory equipment in accordance with SOPs, working instructions procedures and testing monographs, and document properly in a timely manner.
? Be able to identify the critical points for microbiological management.
? Perform lab equipment qualification, method transfer and validation.
? Problem solving for analytical equipment and processes.
? Contribute to problem solving associated with laboratory work such as OOE/OOS investigation.
? Maintain high level of safety, environmental protection and housekeeping in all laboratory operations, comply to relevant Quality System cGMP requirement. Contribute also in the system establishment.
? Take responsibilities in assigned projects as appropriate.
? Be a valuable team member of Quality organization and develop self and others (e.g. junior lab staff/new comer training) through close teamwork and cross functional/sectional activities. Be a continuous improver.
Key Performance Indicators (Indicate how performance will be measured)
An accurate suppliers list is maintained and updated on a periodic basis, posted, and archived.
? The number and severity of cGMP observations identified during internal and external audits.
? Testing of products according to agreed delivery times.
? No safety incidents.
Job Dimensions (Indicate key facts and figures)
Number of Staff: 1 Direct: Indirect: 4-5
Financial responsibility: microbiological cost control
(Budget, Cost, Sales, etc.)
Impact on the organization: Internal: n.a. External: n.a.
CANDIDATE’S PROFILE
Background (State the preferred education, qualification and experience level)
? College or University level. (Microbiology, Biochemistry, Pharmaceutical etc.)
? Attainment of qualified/responsible person status under local/international legislative requirements
? Local language, English speaking, reading and understanding
? At least 5 years of Microbiological test/supervision experience in QC lab from Vaccine manufactory, Drug Product manufactory. Physical and chemical tests experience and SAP system operation will add value.
? Cross-functional working environment
? Has experience of internal and external inspections
Job specific Competencies & Skills (Describe the skills, personal abilities and behaviours that are required for the effective performance of this job)
？ Skilful in using office application software (MS-Word, MS-Excel, MS-Outlook)
？ Be able to work independently. Coach junior employee to perform
the analysis work within cGMP environment and minimize labora-tory errors
？ Challenges ’status-quo’
？ Inter-cultural competence
？ Opportunities
？ Overseas training in EU.
？ Lead a group of technicians in microbiological lab.
？ Extent knowledge in microbiological lab (CCM&RTU).
？ Flexible working time.
？ Different career opportunities in quality department in future e.g. pro-motion, job rotation opportunities within QC (Micro lab to PIS lab) or across QA/QC to build systematic quality concept.
职能类别： 药品生产/质量管理 质量管理/测试主管(QA/QC主管)
公司介绍
默克集团(Merck KGaA)创建于1668年，拥有约350年历史，总部位于德国达姆施塔特市(Darmstadt)，该集团主要致力于创新型制药、生命科学以及前沿功能材料技术， 并以技术为驱动力，为患者和客户创造价值。
截止2012年，默克在全球67个国家和地区拥有154个分支机构，以及38,000名员工。
在中国，默克主要从事制药、生命科学和化工业务，并为客户提供从创新型的处方类药品、非处方类药品到生命科学领域的解决方案，工业用途的效果颜料和化学品。默克的业务主要分为三大分支:默克医药健康业务分支、默克生命科学业务分支、高性能材料业务分支
截止2012年，默克在全球67个国家和地区拥有154个分支机构，以及38,000名员工。
在中国，默克主要从事制药、生命科学和化工业务，并为客户提供从创新型的处方类药品、非处方类药品到生命科学领域的解决方案，工业用途的效果颜料和化学品。默克的业务主要分为三大分支:默克医药健康业务分支、默克生命科学业务分支、高性能材料业务分支
联系方式
- 公司地址：洪山区未来三路
- 电话：15162770233