※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Position] External Manufacturing QA Operations Coordinator
[Salary] 6〜8 million JPY ※Experiences and skills will be considered
- Coordinates deviations from third-party contractors in the context of manufacturing of APIs, bulk, intermediates, final drug products including quality control, medical devices and transportation.
- Escalate critical deviations and complaints to line management.
- Supports resolving deviations and implementation of CAPAs assuring timely completion. Must use scientific judgment to ask key questions during root cause investigations.
- Coordinates and assesses product technical complaints (root cause, impact/risk assessment), ensuring investigation statement timely completion in complaint database.
- Manages changes from third-party contractors as Local Change Manager in change management database including review and approval of related documents and Bill of Materials.
- Tracks timely preparation of APQRs. Compiles PQR summary reports. Checks/reviews PQR Data and escalates discrepancies to line management.
- Prepares and updates SOPs and quality documents in area of responsibility.
- Key-User for IT systems for changes, deviations, complaints and CAPAs.
- Provide support in the context of regulatory agency inspections and requests from Health Authorities.
- Maintain awareness of current GMP trends (e.g. FDA, EMA, PhEur, JP) and pharmaceutical manufacturing processes. Supports continuous improvement within QA.
- Provide tracking of KPIs and support data review of key quality attributes and its trending e.g. of critical process parameters and critical quality attributes.
- Provide expertise and support for projects/launches/changes on request by management.
- Experience in the management of external manufacturers (Third parties / CMO) preferred.
- General knowledge and experience in pharmaceutical subject matter areas including: Manufacturing of bulk, intermediates and final containers; Product inspection and labeling; QC testing; Product disposition and release; Deviation management; Change management; Contract manufacturing
- cGMP experience and knowledge, QA/QC and regulatory compliance (US and other international health agencies).
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Quality Assurance