Responsibilities:
– Maintain pharmaceutical license and GDP authorization for the designated site
– Perform duties of the ‘Fachtechnisch verantwortliche Person (FvP)’ in compliance with relevant local regulations to maintain required licenses
– Assure that the distribution of medicinal products, nutritionals, cosmetics and medical devices conform to Good Distribution Practices, applicable quality standards and regulatory standards
– Ensure that medicinal products sold and distributed conform to Good Distribution Practices and applicable regulatory standards
– Maintain Quality system at site and prepare/maintain all Standard Operating Procedures (SOP) related to Global Distribution and Logistics, including training, internal audit program, document control, quality manual and quality management review
– Complaint management related to Global Distribution and Logistics
– Supervise returns
– Support market action process
– Provide GDP support to relevant regions
– Manage qualification including selection, approval and management of Third Party warehouses, Logistic/Transport Service Providers, distributing global products, and Third Party Laboratories; maintain Approved Supplier List
– Provide necessary support, including training of applicable standards, to service providers
– Ensure Bona Fides of customers for the site
– Create overall Product Quality Review (PQR) reports for related products
– Participate in distribution projects and provide QA compliance
– Work closely with stakeholders to ensure GxP compliance in areas related to counterfeit prevention, distribution suppliers, temperature excursions and monitoring, product transport optimization and qualification, serialization, supply chain validation, material listing approval, and implementation of quality standards
Qualifications:
– Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area; Master Degree desired
– Minimum 5+ years combined experience in QA and/or Development/Operations/Pharmaceutical Engineering function in Pharmaceutical environment
– Prior exposure as Qualified Person/Responsible Person is a plus
– Knowledge of Swissmedic regulations, EU GMP/GDP and other international legislations and standards, e.g. PIC/S, WHO, ICH
– Experience in conducting and handling audits and inspections
– Troubleshooting and issues resolution skills
– Ability to communicate effectively, both orally and in writing to both internal and external audience
– Teamwork attitude
– Ability to use Quality Risk Management tools
– Fluent English and German or French
– Ability to travel in all continents (10%)
Benefits:
– Supportive work environment
– Opportunities to collaborate with stakeholders
– International work exposure
– Professional development in a regulated environment