Quality Assurance Specialist, Document Control (Tokyo, JP)
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ポジション概要 :
GQP/GMP 省令に基づいて制定される品質システムの各手順書（ SOPs ）及び品質標準書、品質システムで作成される様式等、その文書管理業務全般の運営・維持管理を担当いただきます。規制当局の査察に対応できる強固な文書管理システムの策定及び運用を通じて、製品品質、コンプライアンスの遵守に努めます。
また、 GQP の出荷判定業務において、出荷判定関連文書の一次レビューを担当いただきます。
職務内容 :
GQP 省令、 ICHQ10 に基づく GQP 手順書（ SOPs ）、品質標準書の改訂。
Global SOP と Local SOP のギャップ分析及び国内規制要件に基づく適切な改訂。 WEB 文書管理システムへの SOPs の登録。
Data Integrity に基づく文書・紙媒体での保管管理、電子媒体でのバックアップ管理。それら文書の適切な廃棄。
GQP 品質保証業務における年次照査報告書の作成。
GQP の出荷判定業務における一次レビュー、並びに出荷判定関連書類の作成。
その他の GQP ・ CMC 関連業務。
職務経験 :
製薬企業で GQP/GMP 分野での文書管理の実務経験（ 3 年以上）
薬機法、 GQP/GMP 省令に基づく Data Integrity に関する基本的な知識
Word, Excel, PDF 編集ソフト等を活用した文書作成・データ管理
GMP/GQP での出荷判定関連業務の経験を有する方（ GQP での経験を歓迎）
製造販売業の品質保証部門での業務経験（ 3 年以上を歓迎）
必要とする能力・スキル :
細部まで注意を払い、正確かつ着実に業務を遂行できる方
関係部署（薬事部、サプライ＆ディストリビューション、製造所等）とスムーズに意思疎通が図れるコミュニケーション能力
規制動向や社内プロセスの変化に対し、柔軟かつ主体的に対応できる方
英語：ビジネスレベル
資格／免許 :
特になし
Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.
At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.
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Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 1523 comparable Quality roles across 149 biopharma companies.
Salary context
248 of 1523 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1523 comparable roles
+ 47 more countries
Seniority mix
690 of 1523 peers have a known seniority level
Therapeutic area mix
1 of 1523 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
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How we calculate "similar"
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.