· 12 - 13 years (10+years)

·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

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 customer’s 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 etc.).
• 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


• In Summary
• Overseeing PV activities performed by Wipro, in this case the collection and processing in CQ of the complaints and PAEs
• Ensuring that the activities they perform comply with GVP and their SOPs/WIs comply, including self-inspection and record management.
• Be involved in any audits by regulators or MAHs
• Train staff at Wipro that are dealing with Japan in GVP
• Co-ordinate with customer and the other MAHs