Job?Description:
The?Quality?&?Validation?Assurance?department?at?NNE?China?is?looking?for?an?energetic?and?enthusiastic?person?to?join?our?team?of?Quality?Engineers?in?our?Shanghai?office.?As?a?Quality?Engineer?with?NNE?you?will?be?working?with?a?range?of?quality?issues?in?our?capital?investments?projects?within?the?pharmaceutical?and?biotechnology?industry.?Your?main?responsibility?is?to?assure?that?the?projects?are?executed?efficiently?and?all?customer?and?health?authorities’?requirements?are?fulfilled.
? Communication?and?coordinating?with?customer?at?site?to?execute?the?calibration?of?critical?instrument?and?validation?activity?according?the?NNE?procedure.
? Prepare?the?qualification?documents?e.g.?risk?assessment,?protocols,?executing?qualification?and?testing,??in?accordance?with?NNE?procedures
? Maintains?proper?documentation?of?all?validation?activities?in?accordance?with?approved?procedures.?Responsible?for?investigation?and?assessment?of?all?kinds?of?deviation,?which?found?in?validation?activity.?Write?validation?activity?summary?report.
? Familiar?with?clean?utilities,?cleanroom?and?process?equipment?qualification.?Aseptic?filling?or?OSD?process?experience?is?preferred
? Provides?technical?expertise?and?training?to?customers.
? Organize?project?GMP?risk?analysis
? Preparing?audit?documents
Qualification:
You?have?the?following?background:
? National?and?international?GMP?knowledge.
? Validation?experience.
? ISO?9001:2000?knowledge.
? Experienced?in?GMP,?FDA?and?ISO?quality?systems.
? Minimum?a?Bachelor’s?degree?in?the?relevant?field.
? Minimum?5?years?related?work?experience?in?pharmaceutical?or?biotechnology?industry.
? Fluent?in?English?–?both?oral?and?written.
Other?Requirements:
? Accountable?for?results?with?proactive?attitude
? Creative,?self-motivated,?actively?participate?in?specific?initiatives?and?promote?positive?company?culture
? Open-minded?and?ready?for?change
? Willing?to?travel
? Cooperate?and?collaborate?with?business?partners?with?good?teamwork?spirit
? Customer?focus,?understand?and?satisfy?internal?and?external?customers
? Continuously?improve
? Good?communication,?negotiation?and?interpersonal?skills?in?English?and?Chinese
? Detail-oriented?with?good?planning?and?organizing?skill?in?regards?to?the?task
? Provide?high?quality?solution?for?customer?and?work?in?an?efficient?and?timely?manner