Description
Our Swiss based client is urgently looking for two Senior QA/QMS Specialists to support various sites across Europe, India and China and to be responsible for the harmonisation of quality management systems across these sites.This is a fantastic and exciting role to support this long-term project and work in an international environment.
Location: Switzerland - can change to another European site after c. 3 months
Duration: 6 Months +
Start: ASAP
Travel time: approx. 25-50% across Europe, India and China
Tasks:
• Harmonisation of Quality Systems across different sites.
• Provide guidance to sites on implementation of Quality Systems to ensure consistent implementation of the Quality management system.
• Provide operational support and expertise to the site quality units.
• Quality in production areas.
• Troubleshooting if necessary and ensure that issues are resolved according to global standards and consistent across sites.
• Carry out a risk based approach.
• Conduct site Quality Risk Assessments.
• Perform internal inspections and audits.
• Liaise with internal and external stakeholders.
Requirements:
• Experience with the implementation of Quality Management Systems.
• Excellent Quality Assurance experience within the pharmaceutical industry.
• Strong GMP experience.
• Must have experience working in an aseptic environment.
• Experience working with internal and external stakeholders.
• International working experience is required.
• Good communication and organisation skills.
• Fluent English skills required. German / French / Italian is beneficial.
• Bulk Bio experience is a bonus.
• Flexibility and willing to travel internationally.
• Ability to cope with change e.g. moving targets / deadlines / strategies etc.
• Must be able to work independently as a driving force to ensure timely delivery.