Specialist QA Hygiene - German speaking Location: Schaffhausen, Switzerland - Site based
Duration: 24 months
Hours: Full time Imagine your next project working as a Specialist QA Hygiene where you will ensure operational hygiene and compliance in pharmaceutical production at a state-of-the-art site. This role is a site-based position in Schaffhausen, Switzerland, with a duration of 24 months. You will be responsible for monitoring aseptic and non-sterile production areas and acting as a Subject Matter Expert during audits and inspections. roles and responsibilities.
Monitoring aseptic and non-sterile production areas on site with regard to environmental monitoring, gowning and disinfection (hygiene oversight) and assisting in other areas
Timely evaluation of observations within the framework of quality oversight
Identifying risks and opportunities for improvement regarding contamination control and actively implementing defined initiatives in close cooperation with production, the quality department and management
Coordinating and assisting in the analysis and documentation of deviations
Coordination in defining and implementing corrective actions
Controlling and ensuring operational hygiene in pharmaceutical production in compliance with all GMP- and SHE-relevant instructions and regulations
Selection, qualification and demand assessment of hygiene materials
Preparation, adaptation and approval of the hygiene concept, clothing concept and zoning concept according to cGMP
Defining, coordinating and monitoring required hygiene measures according to cGMP standards and the state of the art
Designing and delivering hygiene training for Cilag AG employees and external service providers
Creating, processing and approving records (e.g., Non-Conformances, COCs, CAPAs)
Creating, processing and approving records (e.g., SOPs, WIs and other documents) in the TruVault system
Acting as Subject Matter Expert (SME) during audits and inspections how to succeed.
Degree in a scient...