Job Description
品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...
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...