- FR
Quality Assurance Specialist
Quality Assurance Specialist
About the role
Job Description:
- Contribute to Life Science projects for Antaes Asia clients
- Perform detailed reviews of raw materials, intermediate products, and finished products for compliance with quality specifications.
- Manage the release process by ensuring all quality checks are completed before approving materials and products for use or distribution.
- Ensure that all batch records and associated documentation are reviewed and meet regulatory requirements before product release.
- Provide on-site quality oversight during the manufacturing process, ensuring that all operations comply with Good Manufacturing Practices (GMP) and company quality standards.
- Collaborate with manufacturing teams to address any quality-related issues that arise during production and ensure prompt resolution.
- Conduct regular GEMBA (on-site workplace observation) and GMP (Good Manufacturing Practice) walk-throughs of the manufacturing floor to identify potential quality risks, ensure compliance, and promote a culture of continuous improvement.
- Document findings from walk-throughs and collaborate with the relevant teams to implement corrective actions where necessary.
- Review, revise, and approve Standard Operating Procedures (SOPs), forms, and Manufacturing Batch Records to ensure they are up to date and compliant with current regulations and company policies.
- Ensure that all documentation aligns with current industry standards and best practices in pharmaceutical manufacturing.
- Contribute to the promotion of Antaes services on top of assistance provided to clients
Your profile
Job Requirements:
- Bachelor's degree in Biotechnology, Pharmaceutical or related field
- 3-5 years of experience in quality assurance within the pharmaceutical or biotechnology industry
- Experience with product and raw material release processes and related documentation
- Strong knowledge of GMP (Good Manufacturing Practices) and regulatory compliance
- Hands-on experience in conducting GEMBA or GMP walk-throughs and identifying quality risks
- Proficient in reviewing and approving procedures such as SOPs, forms, and batch records
- Strong attention to detail and ability to work in a fast-paced, regulated environment
- Excellent communication and collaboration skills to work with cross-functional teams
- Good communication and problem-solving skills
About Antaes
Founded in 2007, Antaes is a Swiss management and technology consulting company ranked among the top 15 consulting firms in Switzerland. We employ over 300 experienced consultants who share our passion.
With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:
- Organization and transformation consulting
- Industrial Engineering
- Information Systems Management
By joining our teams you will discover :
- A dynamic team in a start-up spirit
- Human support and career development monitoring
- Challenges to help develop your network
- Events: team building, meet-up, workshop, Winter Event ...
-
An @HappyAtWork certified company with a committed CSR policy (Ecovadis2023 Gold Medal)
Constructeur Joaillerie Expérimenté F/H
Nous recrutons en CDI un Constructeur Joaillerie Expérimenté F/H afin de rejoindre notre pôle d'expertise industrielle dans le cadre d'un projet de grande envergure et longue durée, d'extension des activités de notre partenaire.
En tant que Constructeur Joaillerie Expérimenté F/H, vos missions seront :
- Concevoir les maquettes numériques et les plans de fabrication dans le cadre de l’industrialisation de nouveaux produits ainsi que des démarches d’amélioration continue (cinématique, intégration, ergonomie)
- Assurer la cohérence et la fiabilité des données techniques au sein des environnements PLM, KHEOPS et SAP
- Participer au déploiement de méthodologies CAO visant à optimiser l’efficacité opérationnelle de l’équipe (ex. : modèles 3D annotés)
- Contribuer aux projets d’amélioration continue et à la création de référentiels métiers
- Travailler en collaboration avec les différents services partenaires pour accompagner l’industrialisation des nouveaux produits
- Piloter le lancement des procédures d’achats et assurer le suivi de réalisation des outillages et nouveaux produits en tant qu’interlocuteur technique des fournisseurs
- Élaborer les modèles numériques conformément aux standards et règles en vigueur
- Préparer et accompagner les phases de convergence des projets
- Capitaliser les savoir-faire techniques et favoriser leur diffusion et leur application au sein des équipes
- Participer activement aux initiatives d’amélioration continue des processus et méthodes de travail
Expert Laser - Secteur Industriel H/F
Nous recrutons en CDI un Expert Laser - Secteur Industriel H/F pour rejoindre notre pôle d'Expertise Industrielle, dans le cadre d'un projet de grande envergure et de longue durée d'extension des activités industrielles de notre partenaire.
En tant que Expert Laser - Secteur Industriel H/F, vos missions seront :
- Réaliser les travaux de mise au point et d’ajustement sur les machines en phase d’acquisition
- Développer et paramétrer les recettes de tir selon les besoins de production
- Optimiser et améliorer les programmes existants afin d’accroître les performances et la fiabilité
- Participer activement à l’analyse et à la résolution des problématiques qualité
Développeur IHM / C# / Blazor - Secteur Industriel H/F
Nous recrutons en CDI un Développeur IHM / C# / Blazor - Secteur Industriel H/F pour rejoindre notre pôle d'Expertise Industrielle, dans le cadre d'un projet de grande envergure et de longue durée d'extension des activités industrielles de notre partenaire.
En tant que Développeur IHM / C# / Blazor - Secteur Industriel H/F, vos missions seront :
- Concevoir, développer et optimiser les interfaces homme-machine (HMI) des machines industrielles conformément aux cahiers des charges
- Collaborer activement à l’intégration et à la mise en service des HMI sur les équipements
- Former et accompagner les ingénieurs d’application dans l’utilisation et le support des HMI
- Rédiger, structurer et maintenir à jour la documentation ainsi que les concepts liés aux HMI
- Définir et exécuter les tests unitaires des applications HMI
- Participer à la planification et au suivi des activités de développement des HMI
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Nous recrutons en CDI un Ingénieur Automaticien Beckhoff F/H dans le cadre d'un projet de grande envergure d'extension des activités industrielles de notre partenaire.
As a Beckhoff Automation Engineer F/H, your responsibilities will include :
- Precision machine programming.
- Assembly machine programming.
- Participation in the various phases of the project, from design to documentation, development, commissioning and testing.
- Planning and monitoring of project progress in collaboration with the various stakeholders and project managers.
- Provision of technical support and participation in visits to clients.
CAD/PLM Data Manager F/H
We are recruiting a CAD (Creo) and PLM (Windchill) Technical Data Manager (M/F) on a permanent contract to join our expertise center as part of a large-scale, long-term project to expand our partner's industrial activities.
As a PLM CAD Data Manager, your role will be :
- Migrate various elements from different information systems to the Windchill PLM environment
- Create/modify/update various CAD models and drawings from the old PLM environment in CREO and Windchill
- Support the client teams in deploying new PLM methodologies
Quality Assurance Specialist
About the role
Job Description:
- Contribute to Life Science projects for Antaes Asia clients
- Perform detailed reviews of raw materials, intermediate products, and finished products for compliance with quality specifications.
- Manage the release process by ensuring all quality checks are completed before approving materials and products for use or distribution.
- Ensure that all batch records and associated documentation are reviewed and meet regulatory requirements before product release.
- Provide on-site quality oversight during the manufacturing process, ensuring that all operations comply with Good Manufacturing Practices (GMP) and company quality standards.
- Collaborate with manufacturing teams to address any quality-related issues that arise during production and ensure prompt resolution.
- Conduct regular GEMBA (on-site workplace observation) and GMP (Good Manufacturing Practice) walk-throughs of the manufacturing floor to identify potential quality risks, ensure compliance, and promote a culture of continuous improvement.
- Document findings from walk-throughs and collaborate with the relevant teams to implement corrective actions where necessary.
- Review, revise, and approve Standard Operating Procedures (SOPs), forms, and Manufacturing Batch Records to ensure they are up to date and compliant with current regulations and company policies.
- Ensure that all documentation aligns with current industry standards and best practices in pharmaceutical manufacturing.
- Contribute to the promotion of Antaes services on top of assistance provided to clients
Your profile
Job Requirements:
- Bachelor's degree in Biotechnology, Pharmaceutical or related field
- 3-5 years of experience in quality assurance within the pharmaceutical or biotechnology industry
- Experience with product and raw material release processes and related documentation
- Strong knowledge of GMP (Good Manufacturing Practices) and regulatory compliance
- Hands-on experience in conducting GEMBA or GMP walk-throughs and identifying quality risks
- Proficient in reviewing and approving procedures such as SOPs, forms, and batch records
- Strong attention to detail and ability to work in a fast-paced, regulated environment
- Excellent communication and collaboration skills to work with cross-functional teams
- Good communication and problem-solving skills
About Antaes
Founded in 2007, Antaes is a Swiss management and technology consulting company ranked among the top 15 consulting firms in Switzerland. We employ over 300 experienced consultants who share our passion.
With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:
- Organization and transformation consulting
- Industrial Engineering
- Information Systems Management
By joining our teams you will discover :
- A dynamic team in a start-up spirit
- Human support and career development monitoring
- Challenges to help develop your network
- Events: team building, meet-up, workshop, Winter Event ...
-
An @HappyAtWork certified company with a committed CSR policy (Ecovadis2023 Gold Medal)
