大手外資製薬企業のProduction GMP Supporter

募集要項

仕事内容

As a GMP Supporter, you will play a key role in ensuring compliance with Good Manufacturing Practices (GMP) and driving operational excellence. Your responsibilities will include:

・Support the resolution of deviations (DVs) and quality events by employing systematic problem-solving methods in collaboration with key stakeholders.
・Conduct periodic process confirmations and 5S checks to uphold operational standards.
・Prepare Change Requests (CR) to implement agreed-upon process changes within the Production department and other functions.
・Actively participate in new projects, including new packaging line implementations, by conducting risk and impact assessments.
・Provide guidance on GMP-related tasks to the production team, enhance the Quality Mindset, and prepare or revise Standard Operating Procedures (SOPs), Job Instructions (JIs), and Training Records of Learning (TROLs).

応募条件

【必須事項】

・More than 3 years of work experience in production, manufacturing,　operational environments or in quality department, within a pharmaceutical, medical device or cosmetics company.
・Experience utilizing English in a professional setting, demonstrating excellent communication skills and the ability to thrive in a cross-cultural and cross-functional environment with a highly proactive and professional approach.
・A strong interest in enhancing the Quality Mindset and a desire to improve the overall performance of the production department.
・A self-starter with a proactive approach to completing assigned tasks and involving relevant stakeholders.
・Prior experience or strong interest in continuous improvement and process optimization in a global environment.

【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

3ヶ月

勤務地

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：122
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～800万円　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）二次面接
４）最終面接