Quality Assurance Specialist

• Acting as Deputy QP (FvP), including batch disposition, recalls, and ensuring GDP-compliant
• distribution
• Leading and maintaining the local Quality Management System (QMS) in line with GMP/GDP standards
• Monitoring Out-of-Specification results, deviations, complaints etc.
• Management and scheduling of training
• Conducting management reviews, support with self-inspections, and review of qualification and validation activities on behalf of the RP
• Reviewing analytical methods, specifications, method transfers, method validation, etc. on behalf of the RP
• Assisting and supporting the laboratory team in handling deviations, OOS-results, external complaints and investigations
• Assisting in the laboratory team in setting, changing and approval of product specifications
• Support the Responsible Person with the organization of customer audits and inspections by the authorities

• BSc or MSc in Pharmacy, Chemistry, Biotechnology, or a related field
• Knowledge of Swiss Therapeutic Product Acts and GMP/GDP guidelines
• Several years of experience in GMP/GDP and initial experience in quality assurance within a chemical / pharmaceutical environment
• Validation expertise particularly in the field of equipment qualification, CSV and validation of analytical methods
• Structured and independent personality with a precise and reliable way of working
• Strong analytical mindset with the ability to manage risks, resolve issues, and drive continuous improvement
• Culturally sensitive, enjoy working in international teams and ability to work collaboratively in cross-functional teams
• Excellent communication skills, both written and verbal in English and German

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