【QA】QMS Expert

グローバル スタンダードとローカル規制に沿って品質システムを改善および維持することで品質活動をサポート

仕事内容

・Support Quality activities by improving and maintaining Quality System in line with Global standard and local regulations. Accomplishes quality objectives by planning and evaluating project activities.
・Essential Duties and responsibilities include, but are not limited to, the followings: Maintaining
・Change control, Periodic GMP inspections, Accreditation of foreign manufactures, and Quality agreements.

Key Responsibilities：
1) Maintain change control by timely assessment of quality and regulatory impacts and by ensuring necessary action. Quality impact assessment covers mainly solid oral, antibody injectable, nasal sprays, and cutaneous formulations. Regulatory impact assessment covers effective communication with both Suppliers/CMO and local regulatory team.
Communication is done both in Japanese and English with various suppliers and CMOs worldwide.
2) Maintain periodic GMP inspections and accreditation of foreign manufactures.
Communication is done both in Japanese and English with various suppliers and CMOs worldwide.
3) Perform other duties as assigned such as described below:
4) Provide support for regulatory agency inspection readiness and requests
5) Maintain an annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs
6) Check manufacturing/testing processes in detail to confirm compliance to regulatory approved dossier.
7) Depending on current needs, responsibility may shift to deviation handling, audit etc.

Key Interactions：
(Job roles that interact with inside or outside the company to enable the incumbent to meet Responsibilities)
Internal Stakeholders：
・Contribute to effective and precise communication with Regulatory Affairs team to ensure appropriate regulatory assessment and action as needed.
・Effectively communicate with project team which consists representative of QA, Supply Chain Management, and Regulatory Affairs, especially in the process of adding or changing new suppliers/CMOs. This is to make sure to follow agreed timeline on successful Change control by maintaining GMP inspection and accreditation of foreign manufacturers.

External Stakeholders：
・Effectively communicate with suppliers/CMOs/MF-care-takers and precisely understand their change proposals including their technical backgrounds to ensure appropriate change controls.
・Effectively communicate with suppliers/CMOs/MF-care-takers to manage timeline to ensure successful maintenance of GMP inspection and accreditation of foreign manufacturer especially in the process of adding or changing new suppliers/CMOs to align with project timeline.
・Maintain and conclude quality agreement with CMO following global quality SOP.

応募条件

【必須事項】

・Requires BS/BA (MS or above preferred) in a scientific discipline Certified Quality Auditor (e.g. ASQ) certification preferred
・3 years of related experience in a GQP environment
・Expert skills related to investigations (e.g. Lean Six Sigma) Quality Agreements, and Change Control
・Ability to identify key priorities necessary for and be able to author/implement global policies and procedures
・Expert skills related to Quality Agreements, SOP management and trainings
・Ability to identify key priorities necessary for and be able to author/implement global policies and procedures
・Strong GMP/GQP experience and knowledge, QA/QC and regulatory compliance (Japan, US,EU and other regulatory requirements)
・Experience in drug product sterile pharmaceutical/biologics manufacturing and QC is an asset.
・Team player, task oriented, manage multiple complex priorities and keen on working in a cross-cultural working environment Certified Quality Auditor (e.g. ASQ) certification preferred
・English language fluency, both written and verbal, with the ability to communicate at all levels within the organization (e.g. TOEIC score of above 730); any other language fluency a plus

【歓迎経験】

・Minimum of 5 years of experience in Pharmaceuticals and/or Medical Devices, QA/QC
・Operational knowledge of pharmaceutical processing and packaging operations

【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

在宅可、東京

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
コアタイムあり
　11:00 ～ 12:00
マネージャークラスはみなし労働制

勤務開始日

応相談

休日休暇

年間休日数：125
土日祝
年間有給休暇：入社月により変わります。初年度17～7日　 ～ 23日
法定休暇：年次有給休暇、産前産後休暇、介護休暇
特別休暇：年末年始休暇

年収・給与

年収　　～1000万円　経験により応相談

諸手当

通勤手当

昇給

年1回

賞与

年1回（夏）

採用人数

1名　

待遇・福利厚生

通勤手当：有

各種制度

健康保険：有
雇用保険：有
労災保険：有
厚生年金：有
定年：60歳

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