メディカル・バイオ - メディカルGQP・GMP・品質保証・品質管理

質保証の業務は多岐に渡りますが、患者様のお手元に医薬品を届けるためのキーパーの役割を担っています。その中でも製品品質保証部のコア製品品質グループはノバルティスの多様な医薬品の製品に特化した管理（変更管理、逸脱管理、品質情報）を主軸として、社内外や海外の関係者と日々多く関りながら、製品品質の維持と向上を目指しています。製品の品質を保証するための、活動は決して容易ではありませんが、チームメンバー同士が支え合えながら皆で達成の喜びを分かち合うアットホームな環境です。

Job Purpose:
Based on Novartis Quality Manual and Policies, the following are achieved under local regulations.
• Stable supply to high quality products
• Keep regulatory compliance under cGMP / GQP / GCTP / GDP / QMS and related local regulations
• Satisfy customers from quality point of view

Major Accountabilities:
1. Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures
2. 100% timely delivery of all training requirements including compliance
3. Manage the following regulatory compliance activity under GQP/QMS Work together with other line functions by receiving necessary advice from other NCQ member to keep the compliance of Japan approval files for the products
 Oversight GMP manufacturing sites from GQP point of view
 Entering into quality agreement with manufacturing sites, business partners and maintain it
 Change control related to product quality
 Deviation and CAPA management
 Technical complaint management
 Timely management of periodic regulatory compliance check
 Update existing system and process reflecting new requirements from HA and others. Reduce complexity and simplify the operational process.
4. Quality Management System
 Implement and maintain the local Quality System in GxP areas, in accordance with the Novartis Quality Manual, the NCQ-J Quality Plan, and the local regulatory requirements through:
 Implementation of global quality documents in the Japan Country
 Contribution to the NCQ-J Quality Plan preparation, implementation and follow-up
 Contribution to the Quality Risk Assessments
5. Quality improvement
 Contribute continuous quality improvement in collaboration with relevant business units, manufacturing sites and others
 Contribute to reduce product quality complaints by improvement of product quality
 Manage deviations through proper investigation, CAPA implementation, effectiveness check and trend analysis by receiving necessary support from NCQ member or Quality supervisor
6. Support projects such as new product launch, product transfer, global and/or local initiatives
7. Ensure appropriate interface with authorities for any GxP related activity and provide individual responsibility as a SPOC for health authority if requires.

■休日：完全週休二日制

■Education:
Bachelor of Pharmacy or equivalent

■Experience/Professional requirement:
1. Knowledge of the PMDAct and related regulations
 cGMP / GQP / GCTP / GDP / QMS
 ICH guidelines
 Novartis Quality Manual
2. Knowledge of quality for pharmaceuticals, medical devices
3. Knowledge of Novartis products
4. Person who can engage quality assurance duties properly and efficiently, approved by Quality Assurance Supervisor
5. Complete all necessary training for QA IT system operations
6. Complete the Investigator Certification Program defined by Novartis Training business unit

■English Skill:
• Business level (writing, speaking）
• Preferred: More than 800 score of TOEIC

■職種未経験者：不可