Quality Assurance Specialist – GMP
Sterile manufacturing environment
For our client, a leading pharmaceutical company based in Switzerland, we are looking for a
Quality Assurance Specialist – GMP 100% (Ref. Nr. 3004)
Sterile manufacturing environment
Your main tasks
Ensure GMP compliance across sterile manufacturing operations and cleanroom environments.
Conduct internal audits and manage CAPA (Corrective and Preventive Actions) processes.
Review and approve batch records, SOPs, and validation protocols.
Support regulatory inspections by health authorities (Swissmedic, FDA, EMA).
Lead deviation investigations and implement continuous improvement initiatives.
Your profile
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.
