Pharmaceutical Quality Assurance Engineer
My client is a growing pharmaceutical company based in the French part of Switzerland looking to expand their quality team.
Due to this growth, my client is looking for a Quality Assurance engineer with strong experience in design, qualification and validation to join their team.
• Commissioning and Qualification of the utilities and process equipment.
• Act as the point of contact for quality compliance topics regarding Process Equipment
• Risk assessment exercises
• Review and approve Process Equipment to ensure compliance with cGMP and applicable regulations
• Support the Commissioning & Qualification activities during FAT at suppliers and on site
• Create SOPs for Process Equipment qualification / validation
• Conduct supplier’s audit as well as self-inspections
• Ensure qualification and validation of all equipment in close collaboration with process engineering & automation teams
• Fluent in English and French
• minimum of 5 years in a quality assurance engineering role in a manufacturing environment
• Knowledge of biotechnological technologies
• Proficiency in good practice requirements GMP as well as regulations and standards related to qualification and validation
• Experience in health authorities inspections
• Strong result orientation and committed team member
• Flexibility and ability to travel up to 25% during project
• Strong experience of Quality Assurance engineering and specifically on qualification and validation activities
Please send your CV in English to Jean de La Fournière at email@example.com