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