1.???At?least5?years?of?working?experience?in?injection?molding?process?development.
2.???Have?general?knowledge?in?medical?mold?trial,?validation?and?test?standards?in?the?medical.
3.???Extrusion?knowledge,?Silicone?and?IBM?is?an?added?advantage.?
4.??Good?skills?in?problem?solving?with?tools?and?new?process?continuous?improve.?
5.??Have?RJG?training?is?an?added?advantage.?
崗位職責
1.Improve?and?standardize?validation??process?against?GQP?&?GQMP,?perform?gap?analysis?reports,?establish??action?plan?and?prepare?SOPs.
2.??Routinely?update?site?master?validation?plan.
3.According?to?the?site?master?validation??plan?to?coordinate?the?validation,?revalidation,?validation?review?and?change??control?assessment?for?facility/production?equipment/process/lab?instrument（such?as?Jig）/cleaning??process.
4.Ensure?compliance?with?internal?and??external?validation?system?policies?and?regulations.
5.Organize?/Co-ordinate?site?for?mold?trial??and?molding?process?validation?activities.
6.Assist?in/lead?annual?quality?improvement??projects.?Assist?in?NPI?projects?and?validation/trial?practice?to?ensure??quality?system?in?use?during?these?implementations.
7.??Numbering?and?arching?the?validation??documentation.?Timely?update?and?backup?the?list?for?validation?documents.?Keep??the?documentation?orderly?without?lost?and?archive?timely?before?handover?to??documentation?department?or?administrator.
8.??Participate?in?relevant?file?preparation,?such??as?annual?product?review?and?manufacturing?deviation/investigation,?analyze?the??tendency?of?product?quality?and?raise?the?proposals?to?ensure?that?the?product??quality?will?be?improved.
????????????????????????????????
9.?Be?responsible?for?mold/molding??condition?of?Change?control?management?system,?coordinate?change?related??projects?or?activities?and?charge?review?meetings?periodically.?Be?responsible??for?archiving?and?sorting?of?change?control?documents.?Be?responsible?for??following?up?implementation?action?CAPA.