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无工作经验 -
招1人 -
11-09 发布
职位描述
职位描述： DETAILS OF POSITIONJob TitleQC Supervisor (Microbiological Lab)Grade: 10Reporting toQuality Control ManagerDotted LineFunctionQualityDivision/BUMerck Life Science QualityPlace of workNantong, JiangsuSPECIFIC JOB DESCRIPTIONPurpose 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: 4-5Financial responsibility: microbiological cost control(Budget, Cost, Sales, etc.)Impact on the organization: Internal: n.a. External: n.a.CANDIDATE’S PROFILEBackground (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 inspectionsJob 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 performthe 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)
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开发区苏通产业园
公司信息
默克投资（中国）有限公司
