Expoint - all jobs in one place

The point where experts and best companies meet

Limitless High-tech career opportunities - Expoint

MSD Specialist Quality Systems & Compliance 
Japan, Chiyoda 
743481992

30.06.2024

Job Description

Support the Quality Assurance activities of the Marketing Authorization Holder as described below:
  • Ensure the implementation of GQP Quality Assurance activities and ensure activities operate within established policies/procedures, global requirements, and all applicable regulations.
  • Establish and maintain robust local procedures to support GQP operations.
  • Manage and work closely with manufacturing sites to ensure effective and robust Quality Management Systems are in place.
  • Manage manufacturing site deviations, significant investigations, and change controls as the Marketing Authorization Holder via strong collaboration with Operations and Technical functions including Global functions.
  • Support change control activities associated with regulatory filing updates and new product filings and launches.
  • Support routine GMP audits of manufacturing sites including gap remediation.
  • Support the review of Annual Product Reviews of manufacturing sites.
  • Support compliance activities associated with Japan Pharmacopeia and other compendial updates and changes.
  • Support Quality and Compliance activities associated with regulatory requirements and regulatory notices.
  • Conduct Quality due diligence activities for pre-approval of new external partners.
  • Support Quality activities and engage with external partners for various business deals.
  • Support GQP regulatory inspections for Marketing Authorization license renewal.
  • Collaborates cross-functionally with stakeholders including Regulatory Affairs, Pharmacovigilance, local and global manufacturing sites to support GQP activities for compliant and stable supply of products.

Current Contingent Workers apply


*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.



A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.