日英双语-医药/器械QMS/GCP/GVP审计经理

Experienced：

* As Qualified Safety implementation manager at a global/domestic pharmaceutical companies OR
* As clinical staff at a pharmaceutical company OR
* As an auditor QMS/GCP/GVP audit at CRO

Education Background：

Bachelor’s degree in pharmacy, Medicine or Nursing

Language：

Japanese + English. Japanese (JLPT N2) + English (CET 4)
Roles and Responsibilities
• Thorough understanding of the Japan Medical Device Regulations, MAH GVP requirements. What MAH must do before and after finalizing the GVP agreements between the vendor and the MAH
• Familiarity with the Japanese Pharmaceuticals and Medical Devices Act (PMD Act) and other related regulations.
• To keep the Quality Management System (QMS) updated and compliant with internal guidelines and global standards with regards to the scope and points mentioned by you in trailing mail.
• Domestic PMS activities including reporting to regulatory authorities
• Assist with internal and external audits to ensure adherence to respective standards and regulations
• Manage controlled QMS documentation including SOPs, manuals, and procedures
• Investigate product issues such as complaints and non-conformances, and determine appropriate corrective actions or reporting
• Prior experience with QMS implementation and knowledge of Ordinance No.169 and ISO 13485
• Work closely with MAH and distributor/cross functional teams.
• Set up the QMS - Call handling process, Complaint handling process, RCA – CAPA management
• Perform mock audits for Audit readiness
• Participate and anchor all planned and unplanned customer and regulatory audits
• Any support required in submission
• The QA Safety Implementation Manager also
• Reviews all complaint for Japan to ensure all potential health injuries have been flagged.
• Ensures planning and dissemination of GVP related training in the vendor
• Ensure planning, execution of annual GVP self-inspection and CAPA implementation if needed.
• Day to day tasks
• Receive a list (EXCEL file) of the information registered as complaints in Compliance Quest the previous day from an operations team and review the contents. If a Potential Adverse Event (PAE) is included, record it in the list.
• Regardless of whether a PAE is found or not, send the list to the LifeScan Japan Safety Manager as review record (every business day).
• If the operations team has overlooked the occurrence of a PAE and forgotten to flag it as a PAE in Compliance Quest, provide feedback to the operations team
• Participating in Business Review meetings required by SQA
• Have discussion based on KPIs
• Plan GVP training and ensure the dissemination.
• Plan GVP self-inspection and ensure the execution. Report the self-inspection results to 3 MAHs (NOVA, Asahi, LifeScan Japan).
• Be involved in CAPA discussion for Nonconformance (NC) according to the vendor’s SOP if the NC is a safety matter.
• Participate in supplier audit by the MAHs as auditees