
QC technical director (職位編號:ganlee001782)

職位描述
職位描述:
崗位職責:
Responsibility:
1. provide GMP related QC knowledge training, and build strong QC groups.
2. Lead QC groups to support the following QC activities:
(a) Support clinical and commercial production of Biologics in GMP manufacture.
(b) Assay Qualification/Validation, and release of drug substances and drug products?
(c) Stability study of drug substances and drug products?
(d) Manufacturing trouble-shooting
(e) OOS investigation, especially for sterility and microbiology.
(f) Written and spoken English training
(g) GMP auditing from customer and authority.
3. QC leader of projects
(a) Attend project meetings
(b) Regulatory filing
任職資格:
Requirement:
1. PhD or MS in Analytical Chemistry, Biochemistry or relevant area with at least 10 years experience in QC environment in biotechnology pharmaceutical.
2. Knowledge and experience in protein analytical methods especially GC-MS, residual DNA, residual protein, HMWP, etc.
3. Knowledge and experience in assay qualification/validation to meet FDA/EU and ICH guideline.
4. Knowledge and experience in specifications, reference standard management, and stability study management.?
5. GMP QC experience
6. Strong communication skill
7. Good spoken and written English
企業(yè)簡介
中國胰島素專業(yè)生產(chǎn)企業(yè),國內(nèi)唯一的長效胰島素類似物廠家;【推薦企業(yè)信息】
[展開全文] [收縮全文]職位發(fā)布企業(yè)
甘李藥業(yè)
企業(yè)性質(zhì):民營企業(yè)
企業(yè)規(guī)模:100-499人
成立年份:1998
企業(yè)網(wǎng)址:www.ganlee.com
企業(yè)地址: 漷城西一路附近
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職位發(fā)布日期: 2016-12-16

