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Job Responsibility -Conducts Quality Assurance in-process checks of experiment carried out by technician in laboratory as directed by appropriate Standard Operating Procedures. In-process checks include but not limit to: -ensuring properly calibrated/ validated equipment used; -ensuring personnel performing evaluations in the laboratory is trained & qualified -reviewing of laboratory note book, label and equipment log- books etc. to ensure all testing appropriately documented -Issues Laboratory Notebooks and Equipment Log Books, and maintains lot numbering database. -Be Responsible to distribution, return and update of controlled documents, such as testing method and SOPs; -Maintains electronic version of SOPs; -Drafts new SOP and transfer GSOPs to local SOPs; -Archives all quality records each year, including OOS, CAPA, Deviation, equipment calibration record and so on. -Follows up Deviation, OOS and CAPA log-in and close-out; -Supports ISO 17025 inspection and client audits; -Supports Quality Management Systems such as the Deviation Reporting, CAPA, Document Control and OOS Programs. Also, assists in laboratory investigations of unexpected results and performs internal and external quality audits. -Maintains annual equipment calibration and preventive maintenance plan. -Liaises external calibration, informs related lab for internal calibration, and updates calibration information timely; -Approves equipment internal calibration reports; -Supports equipment qualification and preventive maintenance -Carries out SOPs training to new staff Job Requirements: -Bachelor's degree with 3 years above relevant experience in a pharmaceutical type industry. -Good understanding of GMP or GLP and ISO17025 regulations and integration of regulations into working system in the laboratory -Good English and communication skill and can work under pressure -Capable of handling external audit independently |
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zhangwei19
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2Â¥2011-07-21 16:13:06
zhangwei19
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3Â¥2011-07-21 16:13:36
sgshr
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- ³æºÅ: 1338898
- ×¢²á: 2011-07-06
- רҵ: É«Æ×·ÖÎö

4Â¥2011-07-21 16:14:15
zhangwei19
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- ×¢²á: 2009-07-23
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5Â¥2011-07-21 16:17:02
sgshr
ͳæ (СÓÐÃûÆø)
- Ó¦Öú: 0 (Ó×¶ùÔ°)
- ½ð±Ò: 148.3
- É¢½ð: 5
- ºì»¨: 3
- Ìû×Ó: 183
- ÔÚÏß: 27.4Сʱ
- ³æºÅ: 1338898
- ×¢²á: 2011-07-06
- רҵ: É«Æ×·ÖÎö

6Â¥2011-07-21 16:18:58
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7Â¥2011-08-04 16:24:25













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