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Laboratory Metrology & Qualification Specialist

posted by: spj_bot

About the Role

Join Excelya as a Laboratory Metrology & Qualification Specialist, where you will play a vital role in ensuring the accuracy and reliability of measurements across our laboratory operations. In this position, you will be responsible for developing, implementing, and maintaining measurement and qualification standards in alignment with regulatory requirements.

The consultant will be responsible for ensuring the accuracy and reliability of metrology, verification, and qualification activities for laboratory instruments, equipment, utilities, and controlled environments. The mission covers both initial and periodic qualification phases, including technical validation according to operational and regulatory requirements (GMP and labor code standards).

Main Responsibilities:

  • Health, Safety & Environment (HSE) Responsibilities:
    • Apply and promote site HSE policies and procedures.
    • Identify and report any hazardous situations, ensuring compliance with safety plans.
    • Use personal protective equipment properly and ensure safety devices are not altered.
    • Demonstrate exemplary safety behavior while encouraging safe practices among colleagues.
    • Support continuous improvement in safety culture.

Job Skills

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Assurance Quality Expert - Computerized Systems (CS/QRM)

posted by: spj_bot

Excelya: Your Future Starts Here

At Excelya, we pride ourselves on being a leading mid-size Contract Research Organization (CRO) with over 900 passionate professionals dedicated to improving healthcare. Our core values of Audacity, Care, and Energy guide our actions and decisions as we work collaboratively to drive innovation in clinical research.

Position Overview:

We are currently looking for a knowledgeable and detail-oriented Quality Assurance Expert specializing in Computerized Systems (CS/QRM) to join our dynamic quality assurance team. In this role, you will be instrumental in ensuring the compliance, quality, and effectiveness of our computerized systems and the associated quality risk management processes.

Main Responsibilities:

Job Skills

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Quality Assurance Officer

posted by: spj_bot

About the Job

At Excelya, we take pride in embodying the core values of Audacity, Care, and Energy. As a leading player in the healthcare sector, our mission is to ensure quality and compliance in all our clinical research operations.

This mission is part of a strategic “Data Integrity Enabling Program” aimed at strengthening data governance and ensuring full compliance across all R&D activities. The project focuses on deploying a harmonized data integrity risk-management methodology and supporting critical GxP areas (GCP, GLP, GMP).

Job Skills

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QA officer & RSE

posted by: spj_bot

About the Job

Join Excelya as a Quality & CSR Coordinator, where we value Audacity, Care, and Energy in everything we do. In this role, you will have the unique opportunity to oversee quality management systems and contribute to our Corporate Social Responsibility initiatives, promoting excellence and sustainable practices within our organization.

Your focus will include ensuring compliance with quality standards and regulations while actively participating in CSR programs that align with Excelya's vision for creating lasting positive impacts in our community.

In direct contact with internal teams, suppliers and management, you will structure, lead and improve our Quality Management System while deploying concrete actions in favor of the environment, social and ethics.

In this context, your missions will be as follows:

On the Quality side, you will participate in the management:

  • Updating quality documents (procedures, records, etc.)
  • Qualification of suppliers and monitoring of their commitments
  • Internal audits (from planning to reporting)
  • Gap management and CAPAs, with a real root cause analysis approach
  • Preparation of external audits (customers, ISO, etc.)
  • Monitoring and analysis of quality KPIs to detect drifts and propose solutions

On the CSR side, you will contribute to:

Job Skills

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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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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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Senior CFD Support Engineer - M-Star

posted by: spj_bot

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for a Senior CFD Support Engineer - M-Star in Ireland or United Kingdom.

We are seeking a Senior CFD Support Engineer to become a key technical advisor and subject matter expert in M-Star CFD software. This role is ideal for someone with deep experience in computational fluid dynamics, strong scientific modeling skills, and a passion for helping customers solve complex problems. You will play a critical part in providing advanced support, leading demonstrations, managing simulations, and contributing to R&D efforts. Working closely with clients across the life sciences, chemical, and materials industries, you’ll bring technical expertise and a consultative mindset to ensure high-impact engagement and customer satisfaction. This is a customer-facing role that blends hands-on modeling with strategic technical support, and includes occasional travel across Europe.

Accountabilities:

Job Skills

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Sr. Director/Executive Director, Analytical Development

posted by: spj_bot

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for a Sr. Director/Executive Director, Analytical Development in the United States.

In this role, you will oversee the analytical development and commercial quality control functions for late-stage small molecule programs. You will play a key role in regulatory strategy and execution, ensuring robust analytical methods and high-quality data packages to support regulatory submissions. This position will collaborate cross-functionally with formulation, manufacturing, and quality teams, and interface closely with external partners. It is ideal for a scientific leader with deep technical expertise, a hands-on mindset, and a passion for impactful drug development. The environment is fast-paced, virtual, and mission-driven, requiring adaptability and a solutions-focused approach.

Accountabilities:

Job Skills

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