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
Job Function:
QualityJob Sub Function:
Quality SystemsJob Category:
ProfessionalAll Job Posting Locations:
Shizuoka JapanJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.
Learn more at Major Job Duties and Responsibilities:
GMP/GCTPにおける品質システムコンプライアンスの関わる業務を自ら実施しまたグループスタッフが担当する業務の監督を行う
逸脱プロセスオーナーとして逸脱全般を監督するとともに個々の逸脱の評価調査内容とCAPAの適格性を確認し承認する
GMP査察等に対応し指摘事項に関する継続的な改善をチームの一員として積極的に行う
グループスタッフが担当するGMP/GCTP活動業態管理などの監督を行う
チームメンバーとのコミュニケーションを活発に行い個々の能力開発計画およびキャリア形成をサポートする
継続的な改善のための新しい取り組みをサポートする
トラブルシューティング逸脱調査エスカレーションの準備スタッフのサポート
スタッフのキャリア形成のサポート
新しい取り組みのリードもしくはサポート
Execute quality systems and compliance-related activities in GMP/GCTP and oversee the tasks handled by group staff.
Act as the deviation process owner supervising all deviations evaluating and investigating each deviation and reviewing and approving CAPA for appropriateness.
Manage GMP inspections and other audits actively participating as a team member to implement continuous improvements based on audit findings.
Supervise GMP/GCTP activities and operational management tasks performed by group staff.
Maintain active communication with team members supporting individual capability development plans and career growth.
Support new initiatives aimed at continuous improvement.
Handle troubleshooting deviation investigations preparation for escalation and staff support.
Support staff career development.
Lead or assist with new initiatives.
知識資格及び技能 Knowledge Qualification and Skills:
GMP/GQP/QMS品質システムに精通している
薬剤師資格尚可
ビジネスレベルの英語力を有していることが望ましい
Knowledgeable of GMP/GQP/QMS quality systems.
Pharmacist qualification preferred
Business-level English proficiency is desirable
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Required Experience:
Manager
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