Descripción
--- base: meta-keywords: meta-viewport: width=device-width, title: Quality Operations Senior Specialist -- Sterile Manufacturing --- Quality Operations Senior Specialist -- Sterile Manufacturing ============================================================== 12\\-Month Temporary Assignment \\\| Pharmaceutical Industry \\\| French\\-speaking Switzerland ----------------------------------------------------------------------------------------- For an international pharmaceutical company in the French\\-speaking part of Switzerland, we are looking for an experienced Quality Operations professional with a strong background in sterile pharmaceutical manufacturing and batch release activities. The role supports Quality Operations within an international External Manufacturing environment, with a particular focus on sterile drug product manufacturing, batch documentation and product disposition. We are looking for someone who already brings relevant hands\\-on Quality and sterile manufacturing experience and is ready to broaden their expertise and take on increasing responsibility within product release and Quality Operations. \*\*Start: ASAP \\\| Duration: 12 months\*\* Your Responsibilities • Perform Quality Operations activities supporting sterile drug product manufacturing • Review batch documentation and support batch release / product disposition activities • Review and assess deviations, investigations, CAPAs and change controls • Ensure compliance with cGMP requirements, internal procedures and applicable regulatory standards • Review quality and validation documentation and identify potential compliance gaps • Work closely with external manufacturing partners and internal cross\\-functional teams to resolve quality issues • Support inspection and audit readiness activities • Maintain relevant quality and disposition information in applicable systems • Escalate quality or compliance risks where appropriate • Contribute to continuous improvement and other product qual