Responsibilities????????
?????This???role?is?responsible?for?both?DB?and?GZ?sites,?to?build?up?and?ensure?good?lab???management,?ensure?proper?test?method?used?and?test?process?compliance.???Support?both?sites?in?relevant?quality?improvement?projects.?????
Duties?
a.????Lead?to???establish?relevant?lab?SOP/WIs?and?build?up?lab?management?system??based?on?Good?Laboratory?Practice?(GLP)?and???ISO?17025?system.?
b.????Improve?the???layout?of?lab?infrastructure?to?meet?functioning?requirement?of?micro.,???physical?&?chemical?tests.?
c.????Ensure?the?good?execution???of?GLP?and?conduct?lab?audit,?to?ensure?compliance?and?drive?continuous???improvement.???d.????Ensure?proper???test?methods?and?test?instruments?used,?and?study?the?new?test?methods?to???improve?test?efficiency?and?effectiveness?if?there’s?the?chance.?Study?and???establish?the?test?methods?for?new?test?items?needed?on?raw?material,???packaging?material?and?FG.?
e.????Coordinate?the???lab?OOS?(out-of-spec.)?result?investigation?and?corrective/preventive?action???plan?if?lab?error?confirmed.?
f.???????Conduct?routine?tests?to?share?the?test?tasks?with?lab???assistant?at?DB?site.?Back-up?for?lab?assistant?if?needed.?
g.????Establish?production???measurement?and?lab?test?instrument?Calibration?plan,?and?review?the???effectiveness?of?Calibration?for?proper?disposition?of?the?instruments.?
h.????Support?the???relevant?site?quality?improvement?projects?e.g.?Cleaning?&?Sanitization???improvement?and?verification,?new?production?line?launched,?etc..?
i.???????????Develop?the???competency?of?site?lab?assistants.????????
j.???Other?tasks?assigned?by?site?QA?Mgrs?or?QA?Regional?Director-?South?China.