Quality Operations Senior Specialist – Sterile Manufacturing

h312-Month Temporary Assignment | Pharmaceutical Industry | French-speaking Switzerland /h3 pFor 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. /p pThe 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. /p pStart: ASAP | Duration: 12 months /p h3Your Responsibilities /h3 ul liPerform Quality Operations activities supporting sterile drug product manufacturing /li liReview batch documentation and support batch release / product disposition activities /li liReview and assess deviations, investigations, CAPAs and change controls /li liEnsure compliance with cGMP requirements, internal procedures and applicable regulatory standards /li liReview quality and validation documentation and identify potential compliance gaps /li liWork closely with external manufacturing partners and internal cross‑functional teams to resolve quality issues /li liSupport inspection and audit readiness activities /li liMaintain relevant quality and disposition information in applicable systems /li liEscalate quality or compliance risks where appropriate /li liContribute to continuous improvement and other product quality activities /li /ul h3Your Profile /h3 ul liBSc/MSc or equivalent degree in a scientific or pharmaceutical discipline /li liSeveral years of professional experience in pharmaceutical Quality Operations / Quality Assurance /li liHands‑on experience in sterile / aseptic pharmaceutical manufacturing is required /li liExperience with batch record review and batch release / product disposition /li liSolid working knowledge of GMP quality processes including deviations, investigations, CAPAs and change controls /li liExperience in biologics drug product and/or External Manufacturing is an advantage /li liExperience with SAP and electronic Quality Management Systems is beneficial /li liAbility to work independently while being willing to learn and further develop within Quality Operations /li liStrong analytical skills and a structured, quality‑focused working style /li liExcellent English skills (C1–C2) are mandatory /li liAdditional German skills are an advantage, French is an asset /li /ul pYou are an experienced and hands‑on Quality professional who combines a solid sterile manufacturing background with a strong interest in further developing your expertise in batch release and Quality Operations. You enjoy working across teams, take responsibility for product quality and are comfortable in an international GMP environment. /p #J-18808-Ljbffr