change control

Quality Assurance Pharmacist

posted by: spj_bot

At Excelya, we combine passion, scientific excellence, and collaboration to support our clients throughout the entire drug development lifecycle. We encourage our employees to be bold, take initiative, and unlock their full potential in an international, fast-growing environment.

We are currently looking for a Quality Assurance Pharmacist to strengthen our Quality team and support pharmaceutical quality systems, product quality activities, and regulatory compliance initiatives.

Key responsibilities :

Job Skills

regulatory compliance electronic pharmacovigilance risk management risk assessments quality management system monitor quality portfolio optimization cross functional registration technology transfer pharmaceutical manufacturing collaborating systems product investigations service provider management management activities doctor of pharmacy electronic systems internal audits continuous improvement product quality pharmaceutical quality systems archiving manage quality gmp operational training programs QMS unlock product recall teamwork collaborate drug development collaboration supply chain enthusiasm manage product change control management system consulting quality assurance managing deviations quality management english good manufacturing practice root cause analysis coordinate manage audits
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Spécialiste Assurance Qualité Projets

posted by: spj_bot

Rejoignez Excelya, où Audace, Bienveillance et Énergie sont au cœur de notre façon de travailler. Nous favorisons un environnement collaboratif dans lequel chacun peut développer son expertise et contribuer à des projets à forte valeur ajoutée dans le secteur des Life Sciences.

Dans le cadre de projets stratégiques au sein d'un environnement pharmaceutique, nous recherchons un Ingénieur Assurance Qualité Projets – Qualification & Validation pour accompagner des projets de transfert entrant de produits en formes sèches et conditionnement.

Intégré au pôle Assurance Qualité Qualification, Validation & Projets, vous serez le représentant de l'Assurance Qualité au sein des équipes projets. Vous interviendrez sur l'ensemble des activités Qualité associées aux projets, depuis la définition de la stratégie de qualification jusqu'à l'exécution des qualifications et au suivi du système qualité.

Vos missions :

Job Skills

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Ingénieur Assurance Qualité Projets

posted by: spj_bot

Rejoignez Excelya, où Audace, Bienveillance et Énergie sont au cœur de notre façon de travailler. Nous favorisons un environnement collaboratif dans lequel chacun peut développer son expertise et contribuer à des projets à forte valeur ajoutée dans le secteur des Life Sciences.

Dans le cadre de projets stratégiques au sein d'un environnement pharmaceutique, nous recherchons un Ingénieur Assurance Qualité Projets – Qualification & Validation pour accompagner des projets de transfert entrant de produits en formes sèches et conditionnement.

Intégré au pôle Assurance Qualité Qualification, Validation & Projets, vous serez le représentant de l'Assurance Qualité au sein des équipes projets. Vous interviendrez sur l'ensemble des activités Qualité associées aux projets, depuis la définition de la stratégie de qualification jusqu'à l'exécution des qualifications et au suivi du système qualité.

Vos missions :

Job Skills

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Project Controls Director

posted by: spj_bot

Purpose of the Role

The Project Controls Director holds overall accountability for designing, deploying, and directing a comprehensive, fit-for-purpose project controls system for a new nuclear new-build project.

The primary objective is to give the Project Director and executive leadership an objective, evidence-based picture of project health across scope, milestones, expenditure, actual progress, risks, and emerging changes. Operating within approved project governance, the role ensures that project data directly informs timely, corrective decisions rather than serving solely as historical documentation.

The Director establishes the governance baseline linking Work Breakdown Structures (WBS), organisational accountabilities, budgets, integrated schedules, and performance analytics. Controls must remain proportionate: rigorous enough to spotlight critical-path risks and schedule erosion early, yet sufficiently streamlined to drive action across site delivery teams without excessive administrative burden.

Core Accountabilities

Job Skills

evidence based data flow project management rolling people management nuclear safety dashboards governance contingency allowance negotiation managers leadership team document control targeted construction quality cycle stages systems tools reliable supply chain project budget control constraint management integrated digital code structure dashboard project planning integrate commercial operation global procurement resource loaded quality certification performance management engineering design target licensing interface management mitigation planned performance measurement streamlined system engineering supervise operational coordination variance analysis microsoft project work breakdown structure accountability debated scheduled sequence activities integrated planning root causes progress report project performance controls financial budgets integrated master contract management project governance making and government executing budget power bi track plant operations regulatory compliance leadership mentorship project risks primavera controls unit risk management controls architecture microsoft excel systems revision executive leadership visual engineering site forecasting reconciliation site construction change control govern construction centered accountable fabricators > tracking accruals cash flow control accounts integrated risk analysis life cycle operating planning battery control system cost control cost engineering resource leveling vulnerability milestones management schedules working environment nuclear power transparency scheduling financial accounting long term commissioning analytics procurement schedule case claims audit controls management earn value management mapped collaborative infrastructure forecasts corrective action parameters scale workflow plans critical path method audits
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Chargé(e) assurance qualité CSV

posted by: spj_bot

Rejoignez Excelya, où l'Audace, le Soin et l'Energie définissent notre identité et notre manière de travailler. Nous croyons en la création de solutions ambitieuses et en un environnement inclusif, où la collaboration et le développement individuel vont de pair.

Ce poste représente une opportunité stimulante de rejoindre une équipe dynamique et ambitieuse.

Responsabilités principales

Job Skills

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Microsoft DevOps Engineer

posted by: spj_bot

The Microsoft DevOps Engineer designs, implements and supports secure, resilient and automated Microsoft Azure platforms. The role owns CI/CD pipelines, Infrastructure as Code, cloud operations, monitoring and continuous improvement, working closely with infrastructure, security, application and project teams to accelerate reliable technology delivery.

Key Responsibilities

Azure Cloud Engineering

· Design, deploy and manage Microsoft Azure environments in line with approved architecture and governance standards.

· Support Azure landing zones, networking, compute, storage, backup and disaster recovery services.

· Optimise cloud platform performance, resilience, capacity and cost.

DevOps & Automation

· Design and maintain Azure DevOps CI/CD pipelines using reusable YAML templates.

· Automate infrastructure and application deployment using Terraform, Bicep or ARM templates.

· Manage Git repositories, branching controls, pull requests, artefact versioning and release processes.

· Develop PowerShell, Azure CLI and workflow automation to reduce manual operational effort.

Monitoring & Reliability

· Implement monitoring and alerting with Azure Monitor, Log Analytics and Application Insights.

· Investigate platform and deployment incidents, complete root cause analysis and drive corrective actions.

Job Skills

data models modern microsoft automate infrastructure cloud engineering VPN microsoft certified endpoint management architecture diagrams dashboards governance experience design azure data controls secure python reliable docker operations rest apis microsoft intune business system cloud platform problem solving networking storage data governance resilient ERP root cause analysis microsoft sql server enterprise environments manage diagrams auditing networking compute disaster recovery microsoft designs delivery pipeline operational datum dictionary microservices RBAC storage arm arm vulnerability management stakeholder management kubernetes database design automated azure kubernete service virtual machine scripting azure devops devops incident management yaml power bi indexing database administration engineer designs terraform configuration management reliability automation models entity relationship cloud operation data integration management control agile integration azure azure cloud native data integrity landing zones corrective actions technical solutions collaboration investigate technical documentation change control application deployment git scrum accountable itil foundation certification powershell azure sql database structures planning cloud infrastructure resilience infrastructure security compliance requirement operate microsoft platforms design review azure policy vulnerability management devsecops troubleshooting continuous improvement translate tooling analytical positive templates data lake analytics personal attributes coding application insights infrastructure as code azure monitor agile change operational efficiency infrastructure microsoft azure continuous integration bash workflow factory azure azure services engineer relational database workflow automation audits
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Chargé(e) d'Assurance Qualité Pharmacovigilance

posted by: spj_bot

Rejoignez Excelya, où l'audace, l'attention portée aux autres et l'énergie définissent notre identité et notre manière de travailler. Nous croyons en la création de solutions ambitieuses et en un environnement inclusif, où la collaboration et le développement individuel vont de pair.

Ce poste représente une opportunité stimulante de rejoindre une équipe dynamique et ambitieuse. Vous jouerez un rôle clé dans le support qualité des activités de Pharmacovigilance Quality (PV Quality), en contribuant à la maîtrise des risques identifiés et au renforcement de la conformité globale.

Vos missions principales

Job Skills

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Chargé(e) assurance qualité clinique

posted by: spj_bot

Rejoignez Excelya, où l'audace, l'attention portée aux autres et l'énergie définissent notre identité et notre manière de travailler. Nous croyons en la création de solutions ambitieuses et en un environnement inclusif, où la collaboration et le développement individuel vont de pair.

Ce poste représente une opportunité stimulante de rejoindre une équipe dynamique et ambitieuse.

Dans le cadre d'un recrutement anticipé, nous recherchons un(e) Chargé(e) Qualité Clinique pour accompagner les activités qualité liées aux études cliniques au sein d'un environnement international exigeant et fortement réglementé.

Vos missions

Au sein de l'équipe Qualité Clinique, vous contribuerez notamment à :

Job Skills

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Chargé(e) AQ production

posted by: spj_bot

Rejoignez Excelya, où l'audace, l'attention portée aux autres et l'énergie définissent notre identité et notre manière de travailler. Nous croyons en la création de solutions ambitieuses et en un environnement inclusif, où la collaboration et le développement individuel vont de pair.

Dans le cadre d'un recrutement anticipé, nous recherchons un(e) Chargé(e) Assurance Qualité Production pour accompagner les activités de fabrication et garantir la conformité des opérations au sein d'un environnement pharmaceutique soumis aux BPF/GMP.

Vos missions

Au sein des équipes Qualité et en interaction quotidienne avec la Production, vous serez notamment amené(e) à :

Job Skills

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Leader Regulatory Affairs CMC (drug substance)

posted by: spj_bot

About the Job

At Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a CMC Regulatory Consultant specializing in drug substance lifecycle management to join our dynamic team.

This role involves providing expert regulatory input throughout the lifecycle of small molecule products, from development to post-marketing activities. As a Senior Consultant, you will work closely with cross-functional teams to ensure robust regulatory strategies, compliance, and submission excellence.

The Regulatory CMC Department is looking for a senior consultant with drug substance development experience, he/she will mainly be responsible for leading the regulatory strategy.

Main Responsibilities:

Job Skills

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