Physical Testing Technical Leader--某500强德资医疗公司亚太研发中心

 

Job Description

 

·         Developand establish specifications, develop and validate test methods, performquality testing, and technology transfer of plastic / physical attributes forpackaging materials used for drug products and medical devices.

 

·         Writephysical testing method. Write physical testing method development plan /report, method validation protocol / report, perform physical studies and providetest data to demonstrate R&D of packaging and products.

 

·         Provideefficient and timely documentation and/or transfer of testing technologies.

 

·         Interfacewith physical testing equipment vendors and consultants to improve physicaltesting technologies.

 

·         Understand,interpret and refine package testing procedures and standards to support theeffective design, validation, and implementation of new packages and packagingtechnology. Provide meaningful explanations and forward actions to appropriateDivision/Subsidiary personnel

 

·         Supportline manager and other project managers with Project Management techniques anddevelop project plans.

 

·         Write physical testing equipment standard operationprocedures or working instructions, lead physical testing equipmentqualification and calibration, and establish corresponding equipmentmaintenance instructions.

 

·         Interfacewith cross functions to ensure project meets agreed upon goals. Continuouslyassess and communicate project results vs. goals and take corrective actionwhen required

 

·         Identifyand provide rationale for funds needed to successfully deliver project goals

 

·         Writeand present technical and business summaries for both technical andnon-technical personnel

 

·         Seekout and leverage technology to bring consumer value

 

·         Developand utilize a broad network of technical resources to expedite projectcompletion

 

·         Coordinateoutsourcing testing related to packaging materials, maintain good relationshipwith the laboratory service suppliers, authorities’ certificate labs andindustry committees.

 

·         Develop and validate test method excluding physicaltesting for packaging materials as needed, perform testing and provide testdata timely to support product R&D.

 

·         Supportline manager to lead equipment maintanance.

 

·         Participateroutine laboratory maintanance.

 

 

 

Background

 

·         M.S.or Ph.D. Degree in Packaging, Engineering or Material Science or Analytical

 

·         M.S.with at least 7 years of relevant experience, Ph.D with at least 4 yearsrelevant experiences. Experiencein pharmaceutical packaging evaluation is desirable.

 

·         Previousexperience in a multi-national company is desirable.

 

·         Experiencein the pharmaceutical and/or medical device industry, andfamiliarity with the design control process.

 

·         Experiencein package testing and with package specifications

 

·         Understandingand experience with local and international testing standards.

 

·         Fluentin both spoken and written English and Chinese.