Assistant Manager, Regional Quality Management, Nutrition & Health Japan

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　　COMPANY

　　JOB FIELD

　　JOB TYPE

　　JOB ID

　　LOCATION

　　COMPANY

　　JOB FIELD

　　JOB TYPE

　　JOB ID

　　O bjecti v es of t h e P osi t ion

　　The objective of this position is to take responsibilities to maintain local GMP warehouse for import pharma goods, to provide quality support for EN customers in Japan, to ensure there is adequate support to customer queries on methodology, audit questionnaire, quality agreements, non-conformance management.

　　This position will be the primary Quality contact for EN Asia Pacific reporting to regional quality manager. This position works closely with regional and global team in QM, QC, Regulatory, Sales, Technical support etc.

　　M ain Areas of Responsibilities and Key Activities

　　Quality support :

　　Act as QA in BJL-GMP organization and maintain local GMP warehouse for import pharma goods.

　　Monitoring and understanding relevant laws and regulations related GMP/Quality management.

　　Support / Lead customer communication for quality related topics based on Quality Agreement in accordance with Japan Good Quality Practice (GQP) ministerial ordinance).

　　Working closely with country sales, regulatory, and Supply Chain Management to ensure quality issue is adequately manage and address.

　　Work together with governmental / provincial authorities or Industry associations when applying, interpreting and implementing regulations

　　Act as key responsible for Customer audit request on local GMP warehouse.

　　Conduct and support quality audits according to internal and external guidelines

　　Customer on-site audit include coordinate global on-site audit as a coordinator between functional unit(s), in setting up timeline, process and accompany with customer etc

　　Provide quality compliance related to computer systems implementation and upgrade projects.

　　Provide Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) support, in Quality related topics for Asia-Pacific region.

　　Quality Guidelines :

　　Responsible for the regional rollout, adaption & implementation of quality guidelines

　　Develop and maintain Quality Agreements (customers) and Service Level Agreements (“SLA”) with BASF sites and 3rd party contract manufacturers, Distributors, e.g. draft SLA and Quality Agreements with legal (“ICHQ7”)

　　To handle Non Conformance Management (“NCM”). To be engaging in EN NC community and conducting joint reviews of NCM performance (cases & response time) and counter-measures

　　To coordinate ENP/ ENN/ ENF non-conformances to ensure effective root cause analysis and the implementation of corrective actions (“CAPA”) to minimize customer impact by the reduction of repetitive complaints. Analyse NC trends and work with business partners (external & internal) to recommend / implement changes to EN business processes where required.

　　Material Data & Label Management :

　　Take on the role as regional contact person for SAP material master data and label topicsQuality Community :

　　Actively participate in relevant EN (such as Pharma/Nutrition Health/Aroma etc) trade organizations to keep abreast of industry guidelines and best practices

　　Support Global EN community for qualification of regional suppliers according to the EN guidelines

　　Create communication matrix among the EN quality teams in Asia-Pacific

　　Represent BASF at governmental organizations for the quality part

　　Ensure timely and accurate completion of customer questionnaires, surveys and other information requests in coordination with global teams

　　Job Requirements

　　Edu c a t i o n

　　Bachelor or Master’s degree in Science, or Pharmacy related educationW o r k in g E x pe r i e n c e

　　Minimum of 4-5 years with hands-on experience in excipient testing, strong analytical and GMP background in pharma industry.

　　Good knowledge of Pharmacopeia requirements such as JP, USP, EP etc.

　　Technical & Professional Knowledge, Skills

　　Knowledge in QM-systems, standards & processes, good understanding of laboratory operations & methods

　　Demonstrate cross-functional leadership skills, communication, interpersonal and influence management skills

　　Ability to multi-task, and must be able to organize and direct diverse activities in a changing environment

　　Establish longer term priorities and contingencies, utilizing strong project management skills in order to guarantee successful project completion

　　Willing to travel when required

　　Ability to converse fluently in Japanese and English

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　　Auniquetotal offer: you@BASF

　　At BASF youget more than just compensation. Our total offer includes a wide range of elements you need to be your best inevery stage of your life. That’s what we call you@BASF. Click here to learn more.

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　　Tokyo, 13, JP

　　BASF Japan Ltd.

　　Quality Management

　　Permanent

　　93839

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