Job?Summary
The?core?responsibility?of?the?position?is?to?inspect,?analyse?and?process?all?raw?materials?according?to?CHP,?USP,?EP?and?other?related?requirements.
Main?Responsibilities
??Inspects?raw?materials?in?accordance?with?established?procedures?and?in?compliance?with?CHP,?USP,?EP,?and?related?requirements?to?release?the?raw?materials?within?5?working?days?averagely.
??Submits?accurate,?precise?and?complete?reports?in?a?timely?fashion.?Exhibits?a?working?knowledge?of?Colorcon?Oracle?database?applications?to?maintain?accuracy?of?records.
??Maintains?an?awareness?of?cGMP?and?cGLP?and?maintains?compliance?with?those?regulations;?documents?all?activities?associated?with?cGMP?compliance?(i.e.?instrument?calibration,?OOS?investigations?etc.)
??Prepares?testing?method?for?raw?materials?according?to?global?working?specifications.
??Release?trading?products?and?inputs?data?for?generation?of?Certificate?of?Analysis?from?Oracle?within?2?working?days?averagely.
??Performs?microbial?testing?for?auditing?test?of?finished?goods?and?routine?test?of?raw?material,?and?support?the?environment?monitoring.
??Effectively?communicates?with?supply?chain?personnel?(functions?including?receiving?and?warehouse,?planning?and?purchasing)?in?related?with?the?raw?material?related?issues.
??Performs?other?duties?assigned?by?direct?manager,?including?but?no?limited?to?participate?in?special?projects,?perform?duties?in?compliance?with?Colorcon?laboratory?practices,?training?other?colleagues?in?quality?department.
Key?Performance?Objectives
In?the?first?3?months
Learn?about?company?business/products/key?processes.?Learn?how?to?use?role?based?working?system?(Oracle?and?OneSource?etc.)?to?perform?duties.?Pass?orientation?test?defined?for?the?role?to?demonstrate?understanding?of?the?basic?working?knowledge.
2
In?the?first?6?months?Compete?the?tests?independently?and?timely?based?on?operations?schedule?and?deadlines.?Convert?the?methods?of?CHP?to?the?applicable?Colorcon?QC?raw?material?test?sheets.
In?the?first?1?year?Perform?OOS?investigation?and?complete?reports?accordingly?within?2?weeks.?Can?operate?GC、HPLC、Microbiology?testing?and?AAS?independently.?Achieve?the?key?objectives?set?for?the?role.
Requirements：
??College?or?above?in?pharmacy?or?chemical?or?food?related.
??Minimum?1?years’?experience?in?Chemical?and?instrumental?analysis?in?a?CGMP
pharmaceutical?or?chemical?or?food?work?environment.
??Ability?to?prioritize?the?work?on?a?reasonable?and?effective?basis.
??Familiar?with?pharmacopoeia?compendia,?such?as?CHP,?USP?and?EP.
??Ability?to?use?computer?effectively?including?Outlook,?MS?Office?(Word,?Excel,?and
PowerPoint)?&?good?English?skills?in?reading?and?written.
??Proactive?and?has?high?sense?of?responsibility.
??Be?able?to?work?shift.