Quality Assurance Specialist(m/w/x)

Beschreibung

You will ensure high quality standards by managing document systems and training, while overseeing the release process and quality complaints for the company's medicinal products.

Anforderungen

• •Master's Degree in pharmacy, medicine, biology or equivalent
• •Two years experience in Quality Assurance (GMP/GDP)
• •Knowledge and experience in Learning management
• •Experience with GxP regulations (Swiss, European, international)
• •Experience with quality or workflow management tools
• •Business fluent English and German skills
• •Analytical, problem-solving, and risk management skills
• •Teamwork, communication and problem-solving skills

Aufgaben

• •Administer the Learning Management System
• •Manage training documentation
• •Coordinate and monitor general GDP training
• •Provide first-line support for the LMS
• •Oversee controlled documents in Veeva Vault
• •Support markets with Document Management Systems
• •Review batch certificates against regulatory requirements
• •Record and evaluate transport temperature data
• •Process deviations
• •Administer pharmaceutical quality assurance systems
• •Manage Change Control for GxP-critical areas
• •Review and update standard operating procedures
• •Implement inputs during document reviews
• •Prepare yearly self-inspections for key processes
• •Support continuous Quality Management System improvements
• •Ensure timely review of Product Quality Reports
• •Process and track Product Quality Complaints
• •Provide feedback and metrics on quality complaints
• •Inform Pharmacovigilance regarding suspected adverse events

Tools & Technologien