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Qc specialist

Bulle
Randstad
Inserat online seit: 13 Juni
Beschreibung

JobdescriptionLocation: Bulle, SwitzerlandActivity rate: 100%Contract: temporary contractStart date: 02.06.2025Duration: 12 months UCB, one of Switzerland's Best Employers, is an internationally active biopharmaceutical company specialising in the therapeutic areas of neurological disorders and immunology. The Bulle site is home to the company's Swiss sales subsidiary and primarily a biotechnological and chemical production platform for the manufacture and distribution of pharmaceutical specialities for the treatment of allergy, epilepsy and autoimmune diseases. To support the QC team at UCB's Bulle site in Switzerland, we are looking for a 100% QC Specialist. Your key responsibilities:As a QC Biologics Specialist, you will be a key player in supporting laboratory activities, ensuring compliance, and driving continuous improvement across QC processes. Your main responsibilities will include:Act as SME for analytical methods and lab equipmentSupport QC teams in daily lab operations and technical troubleshootingLead or contribute to deviations, CAPA, and investigationsDraft and revise SOPs, reports, specifications, and quality documentsParticipate in the implementation and qualification of new methods/equipmentEnsure compliance with GMP, GLP, and internal quality standardsPrepare and support regulatory inspections and internal auditsContribute to Product Quality Reviews (PQR) and CPV activitiesIdentify improvement opportunities and lead related initiativesCollaborate with cross-functional teams (QA, Manufacturing, Supply Chain, etc.)Provide input on equipment budgets and investment planningEnsure inspection readiness and maintain accurate documentationAct as back-up for other QC Specialists when neededHelp define and implement QC strategies for analytical processes QualifikationenWhat will make you successful:Bachelor's or Master's degree in Biology, Biochemistry, Chemistry, or related fieldMinimum 5 years' experience in QC within the pharma/biotech industrySolid knowledge of GMP, GLP, and major pharmacopoeias (EP, USP/NF, JP)Proficiency in analytical techniques: HPLC, UPLC, ELISA, bioassays, microbiologyGood understanding of statistics, process capability, and problem-solving toolsExperience with QA processes: deviations, CAPA, investigationsFluent in French and English (written and spoken)Strong organizational skills: able to plan, prioritize, and meet deadlinesTeam-oriented with a calm, structured, and autonomous working styleComfortable leading small projects and training peers when needed

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