Quality Assurance Specialist
GENIX1 THE LAB OF IDEAS is a Swiss Pharmaceutical company founded in 2019, focused on niche products for high growth potential areas worldwide with specific care of niche areas.
The expertise of the Company includes specific business area’s such as Respiratory Generics (DPIs and MDIs), Orphan Drugs, Innovative Medical Devices , Cosmetic and Nutraceutical products. All products have been developed and designed to cover unmet needs of patients by using best-in-class, Industry leading Technology.
We are currently looking for a Quality Assurance Specialist.
Key responsibilities:
- Manage SOPs, market/customers/manufacturers complaints, change controls, deviations, recalls, risk assessments, CAPAs, supplier qualifications and suppliers audits, self-inspections, trainings, management quality review.
- Prepare and manage Quality Technical Agreements.
- Verify the compliance of the quality documents needed for the batch certification.
- Periodical visit and quality support to CMOs. in customers/Health Authorities audits and support all activities to ensure inspection readiness of the department.
- Monitor the updates of SwissMedic and EMA directives and keeping them aligned with the company Quality System.
Key requirements:
- University Education in science (Chemistry, Biotechnology, Pharmaceutical Technology, Biology)
- At least 2 years experience in Pharmaceutical field, specifically in Quality Assurance, is requested.
- Availability to travel
- Requested Language: Fluent in English, Italian welcomed
- Job location: Hybrid , periodically on site based on necessity
- Office location: Chiasso (Switzerland)
Your skills:
- Positive thinking and problem solving capabilities
- Willingness to work in a dynamic team
- Ready to challenge yourself every day
- Strong Communication skills
- Flexible mindset
Apply: Send your CV to enzo@genix1.com