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

Education Background – bachelor’s degree in pharmacy, Medicine or Nursing

Language - Japanese + English

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

o Reviews all complaint for Japan to ensure all potential health injuries have been flagged.

o Ensures planning and dissemination of GVP related training in the vendor

o Ensure planning, execution of annual GVP self-inspection and CAPA implementation if needed.

• Day to day tasks

o 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.

o 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).

o 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

o Participating in Business Review meetings required by SQA

o Have discussion based on KPIs

o Plan GVP training and ensure the dissemination.

o Plan GVP self-inspection and ensure the execution. Report the self-inspection results to 3 MAHs (NOVA, Asahi etc.).

o Be involved in CAPA discussion for Nonconformance (NC) according to the vendor’s SOP if the NC is a safety matter.

o Participate in supplier audit by the MAHs as auditees

• In Summary

o Overseeing PV activities performed by Wipro, in this case the collection and processing in CQ of the complaints and PAEs

o Ensuring that the activities they perform comply with GVP and their SOPs/WIs comply, including self-inspection and record management.

o Be involved in any audits by regulators or MAHs

o Train staff at Wipro that are dealing with Japan in GVP

o Co-ordinate with customer and the other MAHs