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キービジュアル キービジュアル
更新日 2018-09-10
掲載開始日 2018-09-10

Supplier Quality, Sr Consultant

  • ★★★ シニアレベル
  • 上場企業
この求人の
取扱い会社
人材紹介
Michael Page Japan
企業名 会社名非公開
職種
Michael Page Japan
メディカル/医薬/バイオ/素材/食品 - 生産技術/生産管理
メディカル/医薬/バイオ/素材/食品 - 品質管理/保証
業種 製薬メーカー
勤務地 アジア 日本 東京都

仕事内容 Working in a Global team Reporting into Global Supply Chain Head


Description

Summary: Serves as the senior technical expert within department(s) in the Quality
organization. Is responsible for results in terms of quality and conformance to
regulations and company quality policies.
Independently manages Supplier Quality Assurance activities, including:
· Setting quality management system requirements to suppliers
· Managing and overseeing approved supplier list and related supplier
master files
· Ensuring adherence to audit schedule and performance of audits only
by qualified auditors
· Tracking and trending supplier quality metrics
· Coordinating purchasing controls CAPA activities, ensure timely and
effective closure
· Developing processes and systems in alignment with company Quality
Management system
· Coordinating and facilitating integration for acquired facilities and
divestiture of closed facilities into the Baxter Supplier Quality System.
Essential Duties
and

Responsibilities:
· Set Quality system requirements to suppliers, including those for
services, indirect quality relevant purchases (non-BOM), and QS
requirements for suppliers in global markets
· Perform Qualification of suppliers to medical device, pharmaceutical,
combination devices, and/or biologics standards and oversee their
placement on the Approved Supplier List (ASL), including ensuring the
creation and maintenance of supporting evidence (Supplier Master File)
· Conduct and oversee supplier audits-qualification and re-qualification,
including finding closure; Collect, trend and report supplier quality metrics
· Improve/develop quality systems at selected suppliers for QMS and
compliance improvement
· Develop purchasing controls processes, procedures and systems,
including those for BOM, non-BOM, services, spare parts and Third Party
Finished Goods
· Evaluate and improve the effectiveness of purchasing controls and
supplier quality processes and procedures, including Quality Agreements
· Assist in preparing for and defending Purchasing Controls in inspections
by external agencies or internal company audits of Purchasing Controls
processes; Manage and oversee Purchasing controls CAPA, including
root cause identification, and effective and timely closure
· Develop and/or deliver training to internal teams and suppliers.
· Execute SCAR management, effective and timely closure and
Review/risk assessment of Supplier Quality Notifications and their
escalation to SCARs and NCR where needed
· Accountable for NCR as assigned, conducting NCR timeliness and
effectiveness reviews, and trending for corrective/preventive actions,
· Coordinate duties and responsibilities of acquisition or divestiture with the
facility, develop/execute/complete associated protocol and ensure that all
requirements have been completed and facility is live or divested in the
GSQ TrackWise database
· Support Manufacturing, Regulatory, Quality and Purchasing organization
for third party suppliers related activities, as applicable.



◎所属:APACのSupplier Qualityのグループ

(シンガポール勤務者2名、上海勤務者2名、日本で同グループに所属しているのは今回求人しているポジションのみ)

※直接の部下は持ちません



◎Q&A

Q1. Is the person in this position responsible for activities in Japan only or other countries in APAC?

A1. Whilst focus will be Japan based suppliers, there will be activities and audits across Asia Pacific and possibly outside of APAC. Excellent English is a must have. Individual could be travelling 50%.



Q2. Who does the person in this position work with in APAC organization and how does he work with them?

A2. The position will report into the Director of Supplier Quality, Asia Pacific. They will work with the Japan local quality and procurement teams as needed to support and drive change. Their peers will be the other global Supplier Quality team members and especially the Asia Pacific Supplier Quality Hub team.



Q3. What are the initial tasks the person in this position needs to handle when he/she joins company?

A3. Being training in the company systems and process. Become a 'New Supplier Request (NSR) owner' and a certified lead auditor ASAP. The expectation is they can lead audits within 3 months and are able to write technical audit reports in English. Company SQ systems are all in English.


Profile

Qualifications:

· Knowledge of pharmaceutical and/or medical device regulations, e.g.,
ISO 13485, FDA cGMP, MDD, Eudralex, other global or regional
equivalent
· Working knowledge of US and International cGMP for API and Excipients
· Experience in Product/process development and/or supplier quality
improvement;
· For SQA with technical background, a good knowledge of
production/quality development and control methods; CtQ definition,
DfSS, SPC, APQP, FMEA, Control Plans, etc.
· Auditing skillsets, up to and including certified SQ lead auditor training;
Quality Management System auditing, and where possible, special
process auditing skills
· Knowledge of Business Acumen; knowledgeable in current and possible
future policies, practices, trends, technology, and information affecting
his/her industry, business and organization
· Collaboration and Teamwork: Good communications, facilitation,
coordination and team skills
· Project management skills managing multiple issues of moderate to high
complexity relatively independently with minimal supervision/instructions
· Ability to manage the Quality relationship with assigned key
suppliers/stakeholders
· Competence in supporting on-site/off-site supplier quality development
including coordination/management of resources
· Multi-tasking skills in a demanding fast paced environment
· Superior time-management skills
· Attention to details and a passion for quality
· Superior written and oral communications skill sets
· Willingness to travel (up to 30%)

Education
and/or
Experience:
Bachelor's degree in a scientific discipline with 7 years of experience
required or Master's degree in a scientific discipline with at least 5 years
in relevant discipline.
· Requires 5+ years of experience in Quality, Manufacturing, Engineering
or related field; cross-industry experience a plus (e.g., automotive,
aerospace, combination products, pharmaceuticals)
· For SQ Assurance Associates supporting drugs, Pharmaceutical
Manufacturing experience is preferred
· Experience performing laboratory methods
· Experience auditing drug manufacturing facilities
· Experience in root cause analysis, corrective and preventive action
methods; Expertise/experience in problem solving with quality tools such
as 6-sigma / 8-D / CAPA / FMEA / 5WHY etc.
· Experience with data analysis and reporting using basic Excel toolkit and
advanced statistical /process packages such as Minitab or Visio and
PowerPoint.


Job Offer

想定給与:10M-13M+15~20% incentive(経験・前職給与により変動有)


応募は、以下の応募ボタンからお願いします。詳細につきましては、Hiroshi Yamaguchiにお問い合わせください+813 6832 8648。
企業について
(社風など)
Well-known sizeable medical Device company
応募条件 Qualifications:

· Knowledge of pharmaceutical and/or medical device regulations, e.g.,
ISO 13485, FDA cGMP, MDD, Eudralex, other global or regional
equivalent
· Working knowledge of US and International cGMP for API and Excipients
· Experience in Product/process development and/or supplier quality
improvement;
· For SQA with technical background, a good knowledge of
production/quality development and control methods; CtQ definition,
DfSS, SPC, APQP, FMEA, Control Plans, etc.
· Auditing skillsets, up to and including certified SQ lead auditor training;
Quality Management System auditing, and where possible, special
process auditing skills
· Knowledge of Business Acumen; knowledgeable in current and possible
future policies, practices, trends, technology, and information affecting
his/her industry, business and organization
· Collaboration and Teamwork: Good communications, facilitation,
coordination and team skills
· Project management skills managing multiple issues of moderate to high
complexity relatively independently with minimal supervision/instructions
· Ability to manage the Quality relationship with assigned key
suppliers/stakeholders
· Competence in supporting on-site/off-site supplier quality development
including coordination/management of resources
· Multi-tasking skills in a demanding fast paced environment
· Superior time-management skills
· Attention to details and a passion for quality
· Superior written and oral communications skill sets
· Willingness to travel (up to 30%)


Education
and/or
Experience:
Bachelor's degree in a scientific discipline with 7 years of experience
required or Master's degree in a scientific discipline with at least 5 years
in relevant discipline.
· Requires 5+ years of experience in Quality, Manufacturing, Engineering
or related field; cross-industry experience a plus (e.g., automotive,
aerospace, combination products, pharmaceuticals)
· For SQ Assurance Associates supporting drugs, Pharmaceutical
Manufacturing experience is preferred
· Experience performing laboratory methods
· Experience auditing drug manufacturing facilities
· Experience in root cause analysis, corrective and preventive action
methods; Expertise/experience in problem solving with quality tools such
as 6-sigma / 8-D / CAPA / FMEA / 5WHY etc.
· Experience with data analysis and reporting using basic Excel toolkit and
advanced statistical /process packages such as Minitab or Visio and
PowerPoint.
英語能力 ビジネス会話 (TOEIC 735-860)
日本語能力 流暢(日本語能力試験1級又はN1)
年収 経験と能力に基づく   
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Supplier Quality, Sr Consultant

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