Quality Assurance Specialist – GMP

AurigaVision AG seeks a Quality Assurance Specialist to ensure GMP compliance in sterile manufacturing and support regulatory inspections. The role requires 3-5 years of QA experience and knowledge of EU GMP and FDA regulations.

This position is responsible for maintaining GMP standards within sterile manufacturing and cleanroom settings. The specialist will also assist health authorities like Swissmedic, FDA, and EMA during regulatory inspections.

Responsibilities

• Maintain GMP standards in sterile manufacturing and cleanroom areas.
• Perform internal audits and oversee CAPA processes.
• Approve batch records, SOPs, and validation protocols.
• Assist with regulatory inspections from Swissmedic, FDA, and EMA.
• Investigate deviations and drive continuous improvement efforts.

Requirements

• Degree in Pharmacy, Chemistry, Biotechnology, or related field.
• 3-5 years of QA experience in GMP-regulated pharmaceutical manufacturing.
• Hands-on experience with sterile/aseptic manufacturing processes.
• Knowledge of Annex 1, EU GMP guidelines, and FDA 21 CFR Part 211.
• Detail-oriented with strong analytical and problem-solving skills.