Tasks

Primary Function:
  • Maintain the pharmaceutical license and GDP/GMP (GxP) authorization in Switzerland
  • Ensure compliance with the Swiss "Arzneimittel-Bewilligungsverordnung (AMBV)" and the "Heilmittelgesetz (HMG)" as well as all relevant national and international guidelines and internal policies/SOPs
  • Maintain the narcotic drugs license in accordance with the Swiss "Regulation of Narcotic Products (BetM)" and the "Narcotic Act (BetmG)"
  • Ensure that distributed products conform to GxP, EU legislation, local legislation, global policies, and other regulatory standards
  • Technical supervision of pharmaceutical product storage facilities
  • Ensure proper storage, handling, and distribution of medicinal products in accordance with GxP


Main Responsibilities:
  • Liaise with Swissmedic authorities
  • Maintain the quality system, including training, internal audits, quality management reviews, complaints, and returns
  • Support the recall process
  • Approve quality technical agreements
  • Provide GDP support to affiliates (e.g., audits, compliance, events, and exceptions)
  • Select and qualify logistics/transport service providers, third-party warehouses, and distribution centers
  • Ensure QA compliance in distribution projects
  • Collaborate with supply management, distribution, and global product protection to meet GDP requirements
  • Serve as the contact person for quality issues with Swissmedic and other authorities
  • Conduct training as required by corporate quality policies
  • Authorize the return to saleable stock of returned medicines
  • Approve contracts between the contract giver and contract acceptor
  • Report quality issues to Swissmedic
  • Manage quality issues with distribution centers and other partners
  • Oversee and conduct repackaging activities
  • Conduct self-inspection audits
  • Prepare annual narcotic drug accounting for Swissmedic
  • Participate in audits and inspections
  • Update and maintain local QA SOPs in line with national and international guidelines
  • Organize QA training
  • Lead management review meetings

Qualifications

  • Extensive experience in GxP-regulated wholesale and international trade in the pharmaceutical industry
  • Proficiency in MS Office, D2 Documentum, TrackWise, SAP
  • Very good language skills in German and English