Quality Assurance Expert in Injectable and Barrier Technology

Excelya; Gidy; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A healthcare organization in Centre-Val de Loire is seeking an Expert in Quality Assurance for Injectables and Barrier Technology. The role involves leading quality assurance processes and ensuring regulatory compliance. Candidates should have a minimum of 5 years' experience in quality assurance within the pharmaceutical or biotech sectors and must be fluent in French and English.

Qualifications

• Minimum 5 years of experience in quality assurance in the pharmaceutical or biotech industry.
• Focus on injectables and barrier technology.
• Fluent in French and English.

Responsabilités

• Managing task lists and interacting with peripheral streams.
• Drafting quality documents (test protocols/plans, reports).
• Risk analyses and monitoring action plans.

Connaissances

Regulatory requirements knowledge (GMP, ISO)

Analytical skills

Problem-solving abilities

Formation

Master's degree in Life Sciences, Pharmacy, or related field

Description du poste

Overview

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:
• Risk analyses (initiation, execution, conclusion, action plan)
• Drafting quality documents (test protocols/plans and reports, standard operating procedures, operating procedures)
• GAP analysis against GMP (Appendices 1, 13)
• Scientific justification (documents) for deviations from regulatory requirements
• Monitoring action plans, investigations, and evaluation of out-of-specification (OOS) results

Requirements

About You

We are looking for candidates who embody our values of Audacity, Care, and Energy:

• Experience: A minimum of 5 years of experience in quality assurance in the pharmaceutical or biotech industry, with a focus on injectables and barrier technology
• Skills: Strong knowledge of regulatory requirements (GMP, ISO) and quality assurance methodologies. Excellent analytical and problem-solving abilities
• Education: Master\'s degree in Life Sciences, Pharmacy, or a related field
• Languages: Proficient in English and French; other languages are a plus.
• Fluency in French and English is required

Benefits

Why Join Us? At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. Here\'s what makes us unique: We are a young, ambitious health company representing 900 Excelyates, driven to become Europe\'s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient\'s journey. Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.