Quality Control Staff

外資大手製薬メーカーにて医薬品工場における品質管理

仕事内容

The role of the project quality control entails actively participating in the expansion of the facility as the Subject Matter Expert (SME) in Quality Control (QC), while advocating for projects that align with future opportunities. It involves continuously seeking opportunities to introduce new technologies by leveraging external knowledge for new facility and equipment implementations, all while ensuring strict compliance with both internal and external regulations. Embracing the 'Circular for Zero' strategy for design and following the , Essentials, and Triple Bottom Line principles are integral aspects of this role.

・Collaborate with Headquarters (HQ) to implement QC equipment meeting global requirements.
・Review supplier designs and estimates with QC team for lab and equipment specifications.
・Establish maintenance plans and transfer knowledge to KFA QC department.
・Manage stakeholders, particularly the QC department, ensuring compliance with applicable requirements (Good x Practice (GxP), occupational health and safety, environment, etc.).
・Ensure readiness for internal audits and regulatory inspections, act as Subject Matter Expert (SME) during audits, and oversee qualification and validation of new buildings, facilities, and equipment to maintain validated state, prioritizing quality, process performance, and employee safety.

応募条件

【必須事項】

・Bachelor’s degree required.
・Experience as Quality Control at pharmaceutical company.
・Proficiency in Japanese regulations including PMD Act and GMP, as well as ISO9001, PIC/S, and CSV standards is preferred. Understanding of EHS, ISO14001, and OHSAS18001 standards is desirable.
・Knowledge of drug product manufacturing processes, particularly in Quality Control, is essential.
・Business-level English and Japanese proficiency.

【歓迎経験】

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

6ヶ月

勤務地

福島

転勤の有無

転勤なし

受動喫煙防止措置

屋内禁煙

勤務時間

フレックスタイム制
フルフレックス（コアタイムなし）

勤務開始日

応相談

休日休暇

年間休日数：129
土日祝
年間有給休暇：入社半年経過時点10日　10日 ～ 20日
法定休暇：年次有給休暇、産前産後休暇、介護休暇
その他休暇：ボランティア休暇、リフレッシュ休暇など

年収・給与

年収　　500万円～　経験により応相談

諸手当

通勤手当（全額支給）、時間外手当、住宅手当、その他各種手当有
MRの場合上記に加え、営業手当、外勤日当を支給

昇給

年1回

賞与

年2回

採用人数

若干名

待遇・福利厚生

通勤手当：有
確定拠出年金制度

各種制度

健康保険：有
雇用保険：有
労災保険：有
厚生年金：有

選考プロセス

１）書類選考
２）一次面接
３）最終面接