Quality Assurance Specialist GMP R&D

Ceva Santé Animale; Louverné; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

Ceva Santé Animale recherche un Spécialiste en Assurance Qualité pour rejoindre son département de R&D. Le candidat contribuera à la gestion des systèmes qualité en conformité avec la stratégie mondiale de ceva et soutiendra les projets de R&D. Le poste requiert une expérience significative en qualité dans l'industrie biopharmaceutique, avec une compétence en audit et connaissance des réglementations en vigueur.

Prestations

Horaires de travail flexibles

Salaire fixe

Tickets restaurant

Mutuelle et prévoyance

Activités sur site et hors site

Qualifications

• Minimum 3 ans d'enseignement supérieur ou expérience équivalente.
• Minimum 5 ans d'expérience dans un rôle qualité, de préférence en R&D.
• Minimum 2 ans d'expérience en audits internes et externes.

Responsabilités

• Contribuer à la gestion et à l'amélioration des systèmes qualité R&D.
• Former le personnel R&D aux concepts qualité et réglementations GMP.
• Assurer la préparation aux inspections des autorités réglementaires.

Connaissances

cGMP

Communication

Adaptabilité

Coordination

Formation

Diplôme supérieur en science

Description du poste

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Job Reference:

6de15444bb7c

Job Views:

2

Posted:

28.06.2025

Expiry Date:

12.08.2025

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Job Description:

Quality Assurance Specialist GMP R&D

The success of a company depends on the passionate people we partner with.

Together, let's share our talents.

As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.

We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.

Indeed, Our “Together, Beyond Animal Health” vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.

As part of our “Diversity, Equity and Inclusion” policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

Yourmissions :

Working within the Research & Development department and reporting to the R&D Quality Assurance Manager, you will contribute to the management and improvement of R&D quality systems in line with Ceva's global Quality strategy, and provide quality & regulatory compliance support for R&D projects.

Your main responsibilities:

- Site quality and compliance systems:

- Deploy, maintain and improve the site quality system in line with Ceva's global Quality strategy and applicable EU and US GMP regulations.

- Conduct internal and external audits according to annual plan.

- Train R&D staff in quality concepts and GMP regulations.

- Support regulatory authorities' inspection readiness projects according to guidelines, inspection preparation, on-site logistical support during GXP inspections and coordination of inspection responses.

- Support management of deviations, CAPA, change control and SOP system.

- Participate in the validation of computerized systems.

- Project support:

- Ensure that quality and regulatory aspects are taken into account during product development.

- Conduct QA reviews of pivotal studies

Yourprofile :

Education and experience

- Minimum 3 years' higher education, preferably in science, or equivalent experience in the biotech or pharmaceutical industry.

- Minimum 5 years' experience in a Quality role (preferably in R&D).

- Minimum 2 years' experience in conducting internal and external audits.

Technical skills

- cGMP, experience of US regulations (FDA) is an asset, as is knowledge of GLP and GCP regulations.

- Good knowledge of the pharmaceutical development process and regulatory environment.

- Excellent written and oral communication skills in English and French.

- Ability to negotiate with internal stakeholders.

Behavioral skills

- Influence

- Communication skills

- Adaptability

- Coordination skills

Your benefits at Ceva

- Free working hours
- Fixed salary
- Luncheon vouchers (face value 10 euros, 60% paid by the company)
- Time Savings Account
- Incentives, profit-sharing, attractive Company Savings Plan
- Mutual insurance and provident scheme
- CSE benefits and an association offering on-campus activities (yoga, Pilates, fitness, cooking classes) and off-campus activities (afterwork, indoor soccer tournament, etc.).