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Quality officer - Orléans

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. As a Senior Expert in Sterility Insurance, you will take on a vital role in ensuring the integrity and safety of our sterilization processes within clinical development.

Your expertise will drive quality assurance in sterilization practices to comply with industry standards and regulatory requirements while fostering a culture of continuous improvement and excellence.

Main Responsibilities:

- Managing task lists and interacting with other peripheral streams (maintenance, logistics, etc.)

- Communicating tasks to the project manager daily and via monthly KPIs.

- Tasks and deliverables for the project and authorities:

• Risk analyses (initiation, execution, conclusion, action plan)

• Drafting quality documents (test protocols/plans and reports, standard operating procedures, operating procedures)

• GAP analysis against GMP

• Scientific justification (documents) for deviations from regulatory requirements

• Monitoring action plans, investigations, and evaluation of out-of-specification (OOS) results

• Drafting the CCS DP

Requirements

About You

Job Skills

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Quality Assurance Expert in Injectable and Barrier Technology

posted by: spj_bot

Why Join Us?

At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.

As a young, ambitious health company with over 900 talented professionals, we strive to be Europe’s leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.

About the Job

We are seeking an Expert in Quality Assurance for Injectables and Barrier Technology to strengthen our commitment to delivering high-quality products. In this pivotal role, you will lead quality assurance processes, ensure regulatory compliance, and drive continuous improvement initiatives.

Main Activities:

  • Managing task lists and interacting with other peripheral streams (maintenance, logistics, etc.)
  • Communicating tasks to the project manager daily and via monthly KPIs. Tasks and deliverables for the project and authorities:

Job Skills

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Clinical Research Associate

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. As a Clinical Research Associate at Excelya, you will be responsible for overseeing the progress of clinical trials, ensuring compliance with regulatory requirements, and supporting site staff in their efforts to conduct research that improves patient outcomes.

Main Responsibilities:

  • Conduct site initiation visits, monitoring visits, and close-out visits.
  • Ensure site compliance with study protocols, ICH-GCP guidelines, and applicable regulations.
  • Communicate effectively with study sites to facilitate the trial process and address any issues that arise.
  • Review and verify study-related documents and data for accuracy and completeness.
  • Monitor patient safety and data integrity throughout the study.
  • Assist in preparing for audits and regulatory inspections.
  • Provide regular updates to project managers and stakeholders about site progress and challenges.

Requirements

About You:

Job Skills

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Project Manager

posted by: spj_bot

With more than 20 years of proven experience, QUALCO Group stands as a leading provider of Fintech solutions and ICT services, delivering analytics-driven, highly scalable enterprise software solutions in over 35 countries. The Group’s end-to-end technology and ICT services address diverse needs across Banking, Financial Services, Government, Utilities, Insurance, Retail, and more.

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At Quento, we empower our people to innovate and lead in delivering transformative ICT solutions to our clients worldwide. Quento Technologies, the ICT services arm of QUALCO Group, seeks a highly motivated and experienced Project Manager for overseeing and executing complex technology projects.

Responsibilities:

Job Skills

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Demand Planning Specialist

posted by: spj_bot

About the Job

At Excelya, we empower our team to take bold steps in the world of clinical research. As a Demand Planning Specialist, you will be a vital player in ensuring that our operations run smoothly and efficiently. Your role will involve analyzing clinical and non-clinical demands, generating insightful reports, and contributing to the allocation of resources that impact patient care.

Main Responsibilities

  • Consolidate clinical and non-clinical demand reports (API, DP, IMP).
  • Generate IP/DP/DS allocation reports and associated documentation on a monthly basis and as needed.
  • Plan and track product delivery, ensuring alignment with ERP systems.
  • Contribute to the Regulatory Alignment report monthly and on demand.
  • Submit Demand Planning Bulk Manufacturing Order requests.
  • Update marketed product needs in internal systems.
  • Prepare Product Availability Index (PAI) reports.
  • Analyze existing processes to identify areas for optimization and improvement.

Requirements

About You

We seek individuals who are ready to embrace challenges and grow alongside us. To thrive in this role, you should possess:

Job Skills

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Security Testing Specialist

posted by: spj_bot

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At Quento, the ICT arm of the Qualco Group, we deliver comprehensive and innovative solutions across AI, Digital Engineering, Cloud, and Cybersecurity, helping businesses accelerate digital transformation. With a presence in Greece, Luxembourg, and Belgium, and backed by the expertise of the Qualco Group, we combine deep technical knowledge with strategic partnerships to support business growth.

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Quento Technologies seeks a highly motivated and experienced Security Testing Specialist to prepare and execute analysis of the applications from a security point of view. At Quento, we empower our people to innovate and lead in delivering transformative ICT solutions to our clients worldwide. Our high-performing, dynamic, and collaborative environment fosters professional growth at every stage. As a Security Testing Specialist, you will be responsible for including an analysis of the available documentation source code, of the architecture, and penetration testing.

Job Skills

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Senior Development Scientist - Project Leader

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in clinical-ops. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities:

Job Skills

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Clinical Scientist Rare Disease

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

Job Skills

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Sterilization expert

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Safety. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Qualify two sterilization processes at Sterigenics (Minerbio site):

  • Develop and implement the qualification strategy.
  • Prepare product qualification (PQ) documentation.
  • Monitor purchase orders and validation report completion.

Ensure operational follow-up of product qualifications (PQ):

  • Review lots/pallets to be reprocessed.
  • Update and maintain the PQ tracking file.

Optimize the management of product qualifications at the Aubagne site:

  • Identify opportunities for improvement (workflows, traceability, planning).

Strengthen the understanding and monitoring of Operational Qualification/Product Qualification (OQ/PQ) reports:

Job Skills

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Clinical Research Associate Oncology

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

  • Select investigator sites, set up, and monitor clinical studies
  • Establish and track budgets related to clinical studies
  • Contribute to administrative tasks required for the setup and follow-up of clinical studies
  • Conduct monitoring and co-monitoring visits at investigator sites
  • Maintain direct contact with investigator physicians
  • Review clinical instructions when necessary
  • Prepare sites and contribute to audits and inspections
  • Ensure traceability of identified deviations

Requirements

About You

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

Job Skills

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