Quality Operations Senior Specialist – Sterile Manufacturing

Job description

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 quality activities Your Profile • BSc/MSc or equivalent degree in a scientific or pharmaceutical discipline • Several years of professional experience in pharmaceutical Quality Operations / Quality Assurance • Hands-on experience in sterile / aseptic pharmaceutical manufacturing is required • Experience with batch record review and batch release / product disposition • Solid working knowledge of GMP quality processes including deviations, investigations, CAPAs and change controls • Experience in biologics drug product and/or External Manufacturing is an advantage • Experience with SAP and electronic Quality Management Systems is beneficial • Ability to work independently while being willing to learn and further develop within Quality Operations • Strong analytical ski…