[Quality] QA Specialist, Quality Systems [MedTech]
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Monthly Salary:
Posted on:
Vacancies:
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Chiyoda Tokyo JapanJob Description:
SCOPE OF THE ROLE AND BASIC PURPOSE
Key Responsibilities
In theEP/NVQuality assuranceQuality&Regulatory Compliance based on compliance with laws and regulations and internal regulations (J & J Standard etc.) and the quality management system establish the system and manage and supervise the overall QMS system including the management ofNC/CAPAInternal Audit managementQualitysystemmanagement reviewRecord managementand audit addition he/she shall accurately grasp the needs of customers and businessesbuildagood trustedrelationshipwith each FC3rdparty and stakeholders (including overseas) and establish more efficient QMS business processes.
Experience and Skills:
Required:
Knowledge and practical experience oflawsand QMS ministerial requirements
Proactive approach/Able to appropriately demonstrate unique initiatives
Logical Thinking Decision Making and Problem-Solving Skills
Has a strong commitment to achieving goals and a flexible ability to execute.
Excellent written and oral communication skills amonggovernment 3rdparties organizations and individuals.
Business level English proficiency (Conversation reading and writing)
Project and Team Leadership
Ability to multitask.
Preferred:
At least 3 years of experience inquality system/quality assurance/quality control and safety management. (This is acceptable if you are in the pharmaceutical or medical device industry)
Internal/External Audit Implementation and Response Experience (QMS Auditor LicenseHolder)
Experience in the cross-culture/global environment
IT/Digitalliteracy
Education:
Bachelors degree or educational equivalent (Health science or other directly related field or equivalent combination of education is preferred).
主要な責務
EP/NVQualityassuranceQuality&RegulatoryComplianceにおいて法規制や社内規定(J&J Standard等)の遵守及び品質マネジメントシステムQMSに基づき日本の市場における製品及びサービスに関するNonconformance/CAPA管理内部監査の管理マネジメントレビュー品質記録管理監査対応などQMS全般の体制構築及び管理監督を行うまた顧客ビジネスのニーズを的確に把握し各事業部3rdpartyステークホルダー海外含むとの良好な信頼関係を築きより効率的なQMSの業務プロセスを確立する
経験とスキル
必須
法令及びQMS省令の要求事項の知識と実践経験
プロアクティブなアプローチ/独自のイニシアチブを適切に発揮できる
論理的思考意思決定問題解決スキル
目標達成に対する強いコミットメント及び柔軟性のある実行力を有する
行政3rdparty組織及び個人間における文書及び口頭による優れたコミュニケーション能力
ビジネスレベルの英語力会話読み書き
プロジェクトおよびチームリーダーシップ
マルチタスク遂行能力
Preferable
品質システム品質保証品質管理または安全管理における3年以上の経験医薬品または医療機器業界であれば尚可
Internal/External監査実施及び対応経験(QMS Auditor License Holder)
クロスカルチャー/グローバル環境での経験
IT/デジタルリテラシー
Education:
大学卒業(大学卒業以上またはそれと同等の資格を有する者
Required Skills:
Preferred Skills:
Business Behavior Compliance Management Continuous Improvement Data Analysis Data Compilation Detail-Oriented Execution Focus Goal Attainment Internal Controls Issue Escalation Process Oriented Quality Control (QC) Quality Management Systems (QMS) Quality Standards Regulatory Environment Report WritingRequired Experience:
IC
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
