Quality Assurance Specialist

THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO:

• Conduct quality review and approval of GMP documentation (e.g. calibration activity documentation, equipment periodic review, logbooks, training plans and records, SOPs)
• Support quality oversight activities under the responsibility of the Quality Operations and Compliance area (e.g. calibration, equipment periodic review, logbooks, management for training plans and training records, SOPs, quality on the floor)
• Assure and maintain compliance with GMP regulations in the defined scope of work
• Provide support to projects and source areas as Quality Assurance Representative

• BA/BS or higher academic education
• 3+ years of experience in a regulated industry, preferably in pharmaceuticals, biotechnology, or medical technology
• Proficient IT acumen
• Experience in conducting quality oversight activities
• Focus on quality and compliance
• Service- & customer-oriented mindset
• Ability to set priorities and meet deadlines
• Strong problem-solving skills
• Excellent communication skills and fluency in English and German (CEFR B2+)

Additional Skills and Competencies considered a strong asset: 

·        Project Management experience

·        6sigma green-belt certifications