QA Specialist

Job Description:

Responsibilities

• Manage, with the FvP , the implementation and maintenance of an appropriate quality system covering primarily all GxP regulated activities related to development, manufacturing, distribution and commercialization of health care goods and their associated services and solutions.
• To perform quality lifecycle management for dedicated products for Swiss market.
• To take all necessary actions to secure the quality of the products and patient safety.
• Main Accountabilities And Duties
• Quality system management
• Implement and maintain a local quality system applying primarily to SwissMedic-regulated activities related to the import and distribution of products and controlled substances
• Assure compliance with local regulations in Switzerland, international GDP / GMP requirements and the company
• Write SOPs and relevant documents, manage them in eDMS (electronic Document Management System) and support in implementation by training employees
• QA GMP, systems: GMP and process trainings, personal file maintenance
• Providing support to ensure inspection readiness and participation on internal audits and HA inspections
• QA POs executions in Fiori
• Product Quality Management
• Preparation of Market release of purchased or repacked products for Swiss Market: