External Manufacturing QA Operations Coordinator
YOUR TASKS AND RESPONSIBILITIES
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 (CMO reporting versus Bayer reporting) 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.
WHO YOU ARE
University Degree or above
Master degree in (Bio-)Chemistry, Pharmacy, Biotechnology or similar education
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)
Ability to streamline business processes to maximize efficiencies to resolve discrepancies and trending issues
Results oriented and ability to effectively manage multiple, complex priorities
Good communication skills and able to work cooperatively in teams and peer relationships
Ability to work under specific time constraints
Proficiency in spoken and written Japanese and English language
Proficiency in Microsoft applications (e.g. Excel, Word, PowerPoint)
The working location is either in Tokyo or Osaka.
HOW TO APPLY
Please apply for the position through our recruiting website with Japanese resume, Japanese working experience and English CV.
Please find other working conditions at our career site, by coping and pasting the following URL on your internet browser.
Date of Employment : ASAP Division : Pharmaceuticals