Senior QA Associate (80–100%, permanent) – Location: Schaffhausen, Switzerland. Responsibilities
QA responsibility for multiple products. Independent management of projects, e.g., establishment and reorganization of specific areas, process improvements, introduction of new techniques, including within international teams. Handling, tracking, and ensuring timely closure of non-conformances. Advising other departments such as Production, Planning and Engineering in a GMP environment and supporting the implementation of improvements. Ensuring GMP‑compliant processes and documentation. Reviewing batch documentation of manufacturing processes and releasing batches for further processing and final release. Reviewing and approving quality‑relevant master data for materials. Supporting Production on quality‑related issues, including regular walkthroughs/plant rounds. Supporting inspections and audits; acting as subject‑matter expert (SME) for selected areas. Qualifications
Degree in a scientific or technical field. More than 5 years’ professional experience in Quality Assurance or pharmaceutical manufacturing. Experience with NC/CAPAs and CoCs required; experience with supporting tasks such as Risk Assessments, Smoke Studies, etc. appreciated. Background in aseptic manufacturing, hygiene, or microbiology is a definite plus. Comprehensive knowledge of relevant regulations. Excellent German and English communication skills (written and spoken). Confident user of MS Office; GenAI and Copilot. Solution‑oriented, independent, and a team player.
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QA responsibility for multiple products. Independent management of projects, e.g., establishment and reorganization of specific areas, process improvements, introduction of new techniques, including within international teams. Handling, tracking, and ensuring timely closure of non-conformances. Advising other departments such as Production, Planning and Engineering in a GMP environment and supporting the implementation of improvements. Ensuring GMP‑compliant processes and documentation. Reviewing batch documentation of manufacturing processes and releasing batches for further processing and final release. Reviewing and approving quality‑relevant master data for materials. Supporting Production on quality‑related issues, including regular walkthroughs/plant rounds. Supporting inspections and audits; acting as subject‑matter expert (SME) for selected areas. Qualifications
Degree in a scientific or technical field. More than 5 years’ professional experience in Quality Assurance or pharmaceutical manufacturing. Experience with NC/CAPAs and CoCs required; experience with supporting tasks such as Risk Assessments, Smoke Studies, etc. appreciated. Background in aseptic manufacturing, hygiene, or microbiology is a definite plus. Comprehensive knowledge of relevant regulations. Excellent German and English communication skills (written and spoken). Confident user of MS Office; GenAI and Copilot. Solution‑oriented, independent, and a team player.
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Kontaktdaten:
8562-Cilag AG Legal Entity Recruiting-Team
