Basic?Purpose?of?the?Position
1.?Is?responsible?for?establish,?maintain?and?continuously?improve?the?performance?and?reliability?of?the?testing?of?starting?material?and?product,?deviation?handling?and?equipment?and?reagent?management?etc.under?corporate?management?guideline?and?cGMP?regulation?to?ensure?product?quality?in?accordance?with?BI?SOP/cGMP/Registered?Specification.
2.?To?obey?and?improve?all?procedure?to?maintain?a?high?quality?level?and?competitive?cost.
3.To?ensure?QC?department?to?maintain?the?stable?support?to?Value?Stream.
Accountabilities
1.?Organize?the?team?for?carrying?out?daily?sampling?and?testing?for?raw?materials,?packaging?materials,?intermediates,?bulk?products,?finished?products?and?stability?study?product,?testing?for?purified?water?and?waste?water,?finish?the?environment?monitoring?etc，ensure?to?complete?testing?and?releasing?timely.
2.?Release?or?reject?API?/?excipients?/?packaging?material?to?ensure?that?they?comply?with?testing?standard;?and?then?release?/?reject?in?SAP?system.
3.?Establish?Testing?Specifications?for?Raw?Materials?and?Packaging?Materials,?and?relevant?SOPs/Forms?according?to?given?instructions,?ensure?to?comply?with?GMP,?regulatory?and?BI?requirements
4.?Execute?lab?equipment?qualification?and?maintenance;?ensure?to?perform?all?tests?smoothly
5.?Update?SOP?related?to?Product?quality?function?according?to?business?needs?and?regular?review?to?ensure?comply?with?GMP?and?BI?global?requirement.
6.?As?core?member?to?lead?the?Analytical?Method?Transfer?and?AMV?implementation?to?support?the?new?product?launch?and?transfer.
7.?Organize?and?coordinate?tests?and?evaluation?for?supplier?qualification,?tests?and?investigation?for?compliant?samples?and?defected?materials?in?production,?handle?OOS
8.?Establish?and?optimize?the?testing?procedure?creatively?including?management?of?equipment,?glassware,?reagent?etc.?to?continues?improve?the?productivity?and?cost?saving?with?comply?with?requirement?from?SFDA?and?company.
9.?Lead?and?manage?their?team?to?ensure?the?GMP?compliance.
10.?Focus?on?Chemical-lab?related?task.?And?be?a?Micro-lab?backup?of?related?task.
11.?Fulfill?the?other?temporary?task?assigned?by?QC?Manager.
12.?Develop?subordinates?to?build?up?the?talent?pipeline
13.?To?participate?organization?activities?as?key?person.
14.?Provide?technical?skill?training?cross?functional?e.g.?chemical?testing,?sampling,?micro?testing.
15.?Lead?their?team?to?the?cross?functional?supporting?e.g.?FLOW.
16.?Ensure?the?safety?in?the?whole?team.
Required?Capabilities?(Skills,?Experience,?Competencies)
1.?Bachelor?or?above，?Pharmaceutical,?Chemical?or?related?discipline
2.?Experience?of?working?in?a?pharmaceutical?quality?control?environment
3.?Minimum?of?3?years’?experience?of?QC,?of?which?1?year?should?be?at?a?Sr.?Analyst?level
4.?Good?knowledge?of?GMP
5.?Familiar?with?related?local?regulations
6.?Good?team?player
7.?Good?leading?people?skill
8.?Good?organizing?and?communication?ability
9.?Strong?leadership
10.?Sense?of?urgency,?precision?and?reliability
11.?Willing?to?learn?and?open?to?new?ideas,?constructive?thinking,?initiative?and?proactive?12.?Be?able?to?work?under?pressure
13.?Can?create?new?idea?or?innovative?method?to?multiple?functions?能對多項職能進行創(chuàng)新
14.?Good?coaching?ability
15.?Good?time?management?skill
16.?Understanding?of?the?regulatory?requirements?of?the?Pharmaceutical?Industry?including?a?good?working?knowledge?of?GMP?standards,?validation,?supply?chain?processes
17.?Good?problem?solving?skill,?communication?skill
18.?Strong?Leadership
19.?Good?Lean?Concept
20.?Computer:?Familiarity?with?Office?software?e.g.?WORD,?EXCEL,?PowerPoint,?e-mail
21.?Good?English?writing,?reading,?listening?and?speaking