マンパワーグループ株式会社 (人材紹介事業部)

Senior Specialist or Specialist, External Quality Assurance

求人会社名 : 会社名非公開

求人ID : CSP044380-TB

  • 外資系
  • 上場企業
  • 従業員1000名以上
  • 働くママ在籍
  • 年間休日120日以上
  • 土日祝日休み
  • 駅徒歩5分
  • 語学(英語)を生かす
  • 育休・産休・介護休暇実績あり
仕事内容 製造委託先など社外パートナーに関わる品質保証業務:
4.新規社外パートナーに対するDD (Due Diligence)の実施。また、DDやPre Contract Auditで見つかった不備事項に対する改善サポートを行う。

【Main Responsibilities】
Quality Assurance activities for external partners including toll manufacturers.
1.Assures that external partners in Japan operate within established policies/procedures, requirements, and all applicable governmental regulations (GMP, etc.).
2.In strong collaboration with Operations and Technical functions, support market supply and new product launches including pre-approval inspection readiness.
3.Conducts quality due diligence assessments for pre-approval considerations of new external partners. Supports the partner in remediation of due diligence and/or pre-contract audit gaps.
4.Writes, negotiates and maintains a Quality Agreement with external partners. Provides input into the development of commercial contractual agreements with external partners on quality related terms.
5.Works with the External Partner to ensure that effective and robust Quality Systems and Quality management are in place. Provides guidance in the preparation of procedures and guidelines where warranted.
6.Establishes and executes a program of calibrated Quality oversight based on the product type, capabilities, and quality and compliance performance of the external partner.
7.Provides support to the external partners to facilitate and validate new product introductions. Provides compliance input and support, as appropriate for implementation of analytical methodology and process development initiatives. In conjunction with other internal Merck departments, ensures that
応募資格 ・生物学、微生物学、薬学、化学、化学工学、またはそれと同等の学位を持っていることが望ましい。品質保証、品質管理に関する深い知識と幅広い経験。

BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred. Must have strong knowledge of and broad experience in Quality Assurance and Quality Control activities. Must have strong demonstrated communication skills in Japanese and English. Must have demonstrated personal networking and relationship building skills. Must be conversant with all applicable regulations and compendia governing operations. Some level of contractual and financial awareness is required. Strong interpersonal and leadership skills in dealing with a broad variety of cultures on non-routine matters, must have demonstrated personal networking and relationship skills

勤務地 東京都
勤務時間 実働:7時間45分
年収・給与 年俸制
年収:450万円 ~ 1100万円
待遇 正社員
諸手当:通勤手当、交替勤務手当、時間外勤務手当、時間外深夜勤務手当、休日勤務手当 等
福利厚生: 育児休業制度、育児短時間勤務制度、介護休業制度、介護短時間勤務制度、財産形成貯蓄制度、共済会制度、傷病見舞金制度、総合福利厚生サービス利用可(全国約4,000ヶ所のリゾート施設、スポーツクラブなど)
保険: 雇用・労災・健康・厚生年金保険 等
休日・休暇 休日メモ:完全週休2日制(土日)、祝日、創立記念日


求人会社名 会社名非公開
資本金 263億4900万円
従業員数 4,300名
概要 医療用医薬品、医療機器の開発・輸入・製造・販売
業種 食品・医薬品・化粧品


大手外資系製薬会社 Senior Specialist or Specialist, External Quality Assurance