QA Expert Senior
Sede
Svizzera, Neuchâtel, Neuchatel
Settore:
Industria farmaceutica
Ruolo:
Risorse umane
Data ultimo aggiornamento: 19/02/2026 2026-05-19
attività
Descrizione annuncio
If you are interested, please apply with a copy of your CV at the earliest.
This job will halt to accept applications end of February.
Interviews will be online and 2 rounds.
Services
The objective of this resource within the Quality Ops organization is to provide support as a Quality Assurance Senior Expert in the frame of implementation of a new Fill and Finishing. He/she could also be involve in routine GMP operations for Fill and Finishing area. He/she must ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance and regulatory requirements.
This resource will be specifically responsible for the following tasks:
- Approve on the floor aseptic interventions performed by manufacturing during Aseptic Process Simulation.
- Review Master Batch Records.
- Attend all meetings relevant to perform the above-mentioned tasks.
- Respect the escalation process.
- Other tasks related to conventional quality oversight might be occasionally requested to support the team (e.g. continuous improvement initiatives, GMP tour in classified areas, etc.).
Profil recherché
- Formation académique technique et scientifique (bac +5)
- 2?3 d'expériences opérationnelles cGMP dans un département Qualité Ops sur un site de production Pharmaceutique de produits stériles injectables.
- Connaissances holistiques des procédés de production (de la culture cellulaire à la répartition aseptique) : étapes unitaires, équipements, gowning, contrôles d'environnement, tests laboratoires physicochimiques et biologiques, etc.
- Connaissance des référentiels Qualité (cGMP) et des Systèmes Qualité (Déviations, CAPA, Change Control, Training, Documentation, etc.)
- Capacité rédactionnelle pour des documents en français et/ou anglais
- Langues : français et anglais
- Travail sur PC et connaissances pack Microsoft
- Travail en équipe
- Agilité et autonomie
Mode de travail
- Minimum 4 jours sur site
- Reporting au QA manager, mais travail en interaction quotidienne avec Manufacturing, Engineering, Sterility Assurance, Quality Ops, Training, etc.
- Horaire de 2*8 à prévoir pendant les tests de simulation aseptique
If you are interested, please apply with a copy of your CV at the earliest.
This job will halt to accept applications end of February.
Interviews will be online and 2 rounds.
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Annunci di lavoro correlati
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QA Expert Senior
Neuchâtel, Neuchatel - Manpower
For our pharmaceutical client located in Neuchatel, we are seeking QA Expert with experience in routine GMP operations within the Fill & Finish area.
The objective of this resource within the Quality Ops organization is to provide support as a Quality Assurance Senior Expert in the frame of implementation of a new Fill and Finishing and Visual Inspection area. He/she could also be involve in routine GMP operations for Fill and Finishing area. He/she must ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance and regulatory requirements.
This resource will be specifically responsible for the following tasks:
? Prepare, evaluate, and approve controlled documentation, creation/revision.
? Review of deviations in the framework of production events within quality systems (i.e. Trackwise) to verify acceptability and adherence to standard procedures and regulatory requirements. This includes conducting or approving the relevant investigations, impact assessments (related to impact on concerned equipment/product/material) and definition of relevant CAPA.
? Attend all meetings relevant to perform the above-mentioned tasks.
? Approve on the floor aseptic interventions performed by manufacturing during Aseptic Process Simulation .
? Review Master Batch Records
? Respect the escalation process.
? Ensure completion of relevant training and software access management according to Takeda policies.
? Other tasks related to conventional quality oversight might be occasionally requested to support the team (e.g. continuous improvement initiatives, GMP tour in classified areas, etc.).
The above-mentioned tasks are site-based and on-site presence is expected. Home office might be allowed occasionally for specific tasks upon request.
Required Profile
-
Technical and scientific academic background (Master's degree / Bac +5)
-
2?3 operational experiences in cGMP within a Quality Operations department on a pharmaceutical manufacturing site producing sterile injectable products
-
Holistic knowledge of production processes (from cell culture to aseptic filling): unit operations, equipment, gowning, environmental monitoring, physicochemical and biological laboratory testing, etc.
-
Knowledge of Quality standards (cGMP) and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation, etc.)
-
Strong writing skills for documents in French and/or English
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Languages: French and English
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Computer skills and knowledge of the Microsoft Office suite
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Teamwork skills
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Agility and autonomy
Working Mode
-
Minimum of 4 days on site
-
Reporting to the QA Manager, with daily interactions with Manufacturing, Engineering, Sterility Assurance, Quality Operations, Training, etc.
-
2-shift (2×8) schedule to be expected during aseptic simulation tests
Additional Information
-
A 2×8 shift schedule will be required for several weeks during the assignment to support aseptic process simulation activities:
-
06:00 ? 14:30
-
14:00 ? 20:30
If you are interested, please apply with a copy of your CV at the earliest.
This job will halt to accept applications end of January.
Interviews will be online and 2 rounds.
...
24/02/2026
Synergie Production Operator
Svizzera, Neuchâtel, Neuchatel - Manpower
Synergie Production Operator
Expérience dans l'industrie pharmaceutique en inspection visuelle ou dans l'industrie horlogère requise.
Information complémentaire : travail en horaires d'équipe 2x8.
Le technicien de production a pour objectif principal de réaliser les activités liées au processus d'inspection visuelle manuelle d'une substance pharmaceutique active.
Il doit être capable de :
? Respecter les normes cGMP, BDP et EHS
? Réaliser les activités process de routine et hors routine (complétion planning) d'inspection visuelle manuelle
? Remonter les problématiques techniques et/ou organisationnelles
? Assurer le partage de connaissance avec les collègues
? Proposer des idées d'amélioration continues
? Assurer le maintien de l'état des zones de production
Responsilities
- Responsable de respecter les normes cGMP, BDP et EHS
- Responsable du suivi de sa formation
- Responsable de la bonne exécution de son travail
- Responsable de remonter les problèmes rencontrés
- Être à 100% autonome sur les activités de sa zone de travail
- Être impliqué dans l'amélioration continue
- Respect et application des leaderships behaviors
- Respect des processus organisationnels Qualifications
- BAC + 2 (options biotechnologie, chimie, biologie, biochimie) ou équivalent
- Bonnes connaissances dans le procédé suivant : inspection visuelle manuelle ou contrôle sur loupe binoculaire
- Idéalement CFC de technologue en production chimique et pharmaceutique ou diplôme équivalent.
- Idéalement, une première expérience réussie dans l'industrie pharmaceutique, agroalimentaire, chimique ou horlogère.
- Connaissance des règles de Bonne Pratiques de Fabrication (cGMP)
- Connaissance de l'environnement de travail en zone à atmosphère contrôlée
- Connaissances des logiciels du pack office (Outlook, Excel, Word, PWP)
- Bonne communication verbale et écrite en français (niveau minimum B2)
Soft Skills
- Bonne communication verbale et écrite
- Méthode et rigueur dans le travail
- Disponibilité et flexibilité
- Sens de l'organisation
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- Esprit d'équipe
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Please Contact: elaine.kanwar@experis.ch +41 61 282 22 23
...
19/02/2026
QA Expert Junior
Svizzera, Neuchâtel, Neuchatel - Manpower
Experis est le leader mondial des solutions de recrutement professionnel et de gestion de ressources en mode projet.
Pour le compte de l'un de nos clients, un groupe pharmaceutique international basé à Neuchâtel, nous recherchons un(e) QA Expert Junior.
Votre mission En tant que collaborateur Assurance Qualité, vous serez directement rattaché(e) au superviseur Assurance Qualité et responsable de la conformité et de la surveillance de la qualité des activités terrain tout au long du processus de fabrication.
L'Associate Quality On the Shop Floor est le référent Assurance Qualité pour les activités de routine BPF (Bonnes Pratiques de Fabrication) dans les secteurs de production de Substance Pharmaceutique (Bulk Drug Substance) et de Remplissage Aseptique (Fill & Finish) de produits biologiques.
Vous travaillerez en étroite collaboration avec les équipes terrain afin de garantir la production de produits de qualité, tout en identifiant les opportunités d'amélioration et en réduisant de manière préventive les risques de non-conformité. Activités et responsabilités principales
- Revoir la documentation liée aux processus de production en zone (ex. : dossiers de lot)
- Observer les activités critiques en zone de production et soutenir la résolution des problématiques en temps réel
- Assurer une présence continue en zone et collaborer avec les équipes de production pour mettre en ?uvre les actions garantissant la qualité du produit
- Soutenir la conformité aux BPF et aux procédures internes en renforçant le partenariat entre la Qualité et les Opérations
- Coacher les équipes opérationnelles dans la gestion des événements qualité
- Collaborer avec les équipes terrain pour la résolution des problèmes et l'identification des causes racines des déviations
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- Être le point de contact Qualité en zone de production
- Identifier de manière proactive les risques qualité en collaboration avec la production Comportements clés attendus Le / la Quality On The Shopfloor Associate :
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- Travaille en collaboration avec ses partenaires, coache et donne du sens aux exigences Qualité
- Est un partenaire des équipes de production sans se substituer à elles
- Observe, documente et partage de manière factuelle les bonnes pratiques, opportunités d'amélioration et écarts
- Remonte les points observés lors des instances de gouvernance
- Justifie et explique ses décisions
- Transmet ses connaissances et assure un rôle de coaching
- Est capable de simplifier des situations complexes
- Fait preuve d'un excellent sens de l'écoute
- Communique de manière claire et efficace
- Maîtrise parfaitement la langue française
- Utilise couramment le pack Office Éducation et expérience
- Formation académique technique et scientifique
- 2 à 3 ans d'expérience en environnement cGMP, au sein d'un département Quality Operations ou Manufacturing
- Expérience sur un site pharmaceutique produisant des produits injectables stériles
- Bonne connaissance des procédés de production, de la culture cellulaire au remplissage aseptique :
- opérations unitaires
- équipements
- habillage (gowning)
- monitoring environnemental
Si cette opportunité vous intéresse, nous nous réjouissons de recevoir votre CV.
Pour toute question, vous pouvez contacter
Vladyslav Kadaiev au +41 58 307 2092.
En raison des restrictions liées aux permis de travail en Suisse, nous ne pouvons considérer que les candidatures de citoyens de l'UE ou de titulaires d'un permis de travail valide en Suisse.
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Nuovo!
Implementation Workstream Lead
Basilea Città, Basel - Manpower
Experis® is a global leader in IT professional resourcing, permanent recruitment, project solutions, and managed services. With over 25 years of experience in Switzerland and offices in Zürich, Basel, and Geneva, we connect top IT talent with leading companies. Our mission is to help professionals unlock their potential and thrive in dynamic, future-ready careers.
Implementation Workstream Lead
Background:
The Overall Implementation Lead is the central orchestrator responsible for the successful end-to-end rollout of the new customer engagement platform. As the leader of the Implementation Squads Workstream, you will provide strategic direction, managing its integrated plan, budget, and resources, and representing the workstream in key leadership forums. You will own the integrated Implementation strategy and master rollout plan, coordinating the sequence, timing, and dependencies for all affiliates and functions. A key part of this is to drive stakeholder alignment, acting as the primary point of contact for affiliate leadership and global stakeholders to ensure Implementation readiness, manage expectations, and communicate progress. You will also champion a "globally consistent, locally relevant" approach, establishing the process for managing local requirements and variations without compromising the core global solution.
As the primary driver of execution, you will provide cross-squad oversight for all Business Implementation Squads, ensuring they have clear plans and are executing effectively. This requires you to proactively manage all program-level risks, issues, and dependencies, driving resolution and owning the escalation path to leadership. To ensure a seamless transition from "build" to "live" operations, you will define, manage, and track the comprehensive 'go-live' readiness criteria and checklist. This is achieved by working in lock-step with the ECL, Business Process, and RDT (IT) workstreams to ensure all training, communications, and support plans are fully aligned and executed in time with the Implementation schedule.
The perfect candidate brings several years of experience in large-scale program deployment or hands-on project management, with a proven track record of managing technology implementation projects. Also we are looking for someone with an outstanding stakeholder engagement and communication capabilities, with a proven ability to foster trust and ensure clear, consistent communication with both local teams and central program leadership.
General Information:
? Start date: asap
? latest Start Date: 15.04.2026
? Planned duration: 2.5 years
? Extension (in case of limitation): yes
? Workplace: Basel
? Workload: 100%
? Home Office: 2 days onsite minimum
? Travel: 20% global
Tasks & Responsibilities:
? Hold accountability for the successful execution of the deployment plan in your assigned affiliate, including the on-time delivery of all local milestones from pre-launch to hypercare exit.
? Build and maintain a strong, trusted partnership with affiliate leadership and their project team, acting as their single point of contact and strategic guide.
? Lead the performance of the local implementation squad, ensuring the team is motivated, aligned, and effectively resolving all on-the-ground challenges.
? Manage the accurate tracking and reporting of all local business and technical readiness, and proactively mitigate all local risks and issues.
? Consider the local business continuity plan, ensuring that the cutover and go-live phases cause minimal disruption to critical business operations.
? Ensure the local change and training plan is delivered effectively, partnering with ECL and local champions to drive user adoption.
? Represent the affiliate's unique needs and challenges back to the central program, ensuring they are clearly communicated and appropriately addressed.
Must Haves:
? University Degree in Business, IT, or a related field.
? 5-7 years of experience in large-scale program deployment or hands-on project management, with a proven track record of managing technology implementation projects.
? Experience in the pharmaceutical/biotechnology industry is strongly preferred, with a deep understanding of affiliate/local market operations, business processes, and culture.
? 3 years of matrix leadership of distributed teams; you must be able to lead and motivate a local squad without direct authority.
? A "roll-up-your-sleeves" mindset with a proven ability to identify, analyze, and resolve on-the-ground challenges and roadblocks in a fast-paced environment.
? Excellent stakeholder engagement and communication skills, with the ability to build trust and maintain clear, consistent communication with both local teams and central program leadership.
? Hands-on experience in supporting the delivery of local training and change activities to drive user adoption.
? VACC mindset and an openness to new ways of working.
? Able to travel to affiliate/market sites as needed for key milestones (e.g., go-live).
? English fluent is a MUST, other languages are a big PLUS (e.g. French, Spanish, Italian, German)
For this position we can only consider applicants with a Swiss work permit or a Swiss/EU passport.
If you are interested, kindly send us your CV today through the link in the advert.
...
24/02/2026
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