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Proclinical
Quality Assurance Associate (Filling)Proclinical • bern, canton of bern, Switzerland
Quality Assurance Associate (Filling)

Quality Assurance Associate (Filling)

Proclinical • bern, canton of bern, Switzerland
Vor 30+ Tagen
Stellenbeschreibung
pReady to safeguard quality at the heart of aseptic manufacturing and make a real impact in a cutting-edge pharmaceutical environment? /ppProclinical is seeking a Quality Assurance Associate (Filling) to join a dynamic team in Switzerland. This role focuses on ensuring compliance and quality in aseptic manufacturing processes, including deviation management, risk assessment, and GMP adherence. The position offers a mix of office-based responsibilities and on-site activities in cleanroom environments. Flexibility to adapt to changing priorities and occasional work outside regular hours is required. /ppPlease note that to be considered for this role you must have the right to work in this location or hold an EU passport. /ppbResponsibilities: /b /pliManage deviations in aseptic filling and visual inspection processes, including conducting initial assessments and supporting investigation strategies. /liliCollaborate with operations teams to define corrective and preventive actions (CAPAs) and ensure compliance. /liliReview investigation reports in both German and English for compliance and risk assessment. /liliSupport internal and external inspections by preparing and presenting deviation-related documentation. /liliProvide guidance on aseptic manufacturing processes, ensuring GMP compliance without direct hands-on production or lab activities. /liliParticipate in projects such as commissioning new filling lines and implementing regulatory requirements. /liliReview and document aseptic production processes and support employee training and requalification. /liliAssist production teams throughout the manufacturing process, focusing on compliance and risk evaluation. /lipbKey Skills and Requirements: /b /pliDegree in natural sciences (Bachelor's, Master's, or PhD) or equivalent qualification. /liliNative German speaker with strong English proficiency (written and spoken). /liliKnowledge of GMP and pharmaceutical industry practices; experience in QA or aseptic areas is advantageous. /liliStrong analytical skills with the ability to critically assess and structure reports and texts. /liliTeam-oriented mindset with excellent communication and interpersonal skills. /liliAbility to manage multiple projects, adapt to changing circumstances, and meet strict deadlines. /liliWillingness to occasionally work outside regular office hours to observe production processes. br/ /li
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Quality Assurance Associate (Filling) • bern, canton of bern, Switzerland

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