CQV compliance Specialist - CDD

Evotec; Toulouse; Sur place; EUR 55 000 - 75 000; Temps partiel

Résumé du poste

Evotec recherche un CQV Compliance Specialist (F/M/D) pour Toulouse, dans un cadre MSAT/CQV et au sein d’une équipe en évolution suite à l’acquisition Sandoz. Vous veillerez à la documentation et aux systèmes qualité, et travaillerez avec les départements qualité et fabrication pour assurer la conformité et l’excellence opérationnelle.

Le candidat idéal possède un diplôme scientifique avec 4–5 ans d’expérience en environnement cGMP, maîtrise du FR/EN et des méthodes d’analyse des causes

Qualifications

• Bachelor’s degree en domaine scientifique/engineering avec 4–5 ans d’expérience en environnement de fabrication cGMP.
• Français et Anglais courants avec de solides compétences en communication et gestion des parties prenantes.
• Expérience en investigations de causes profondes et en méthodologies de gestion des risques (FMEA).
• Bonne compréhension des exigences cGMP, déviations, CAPA et change controls.

Responsabilités

• Fournir et coordonner la documentation qualité et conformité pour les équipes MSAT.
• Agir comme partenaire clé pour les déviations, CAPA, change controls et plans d’action.
• Conduire et soutenir des enquêtes liées aux déviations et assurer la mise en œuvre corrective et préventive.
• Analyser les tendances de conformité et identifier des opportunités d’amélioration.
• Gérer le cycle de vie documentaire (SOP, révisions, mise en œuvre).
• Suivre l’exécution et la clôture des enregistrements qualité et actions de conformité.
• Collaborer avec les équipes Quality, Manufacturing et MSAT pour renforcer les processus.

Connaissances

cGMP knowledge

Root cause analysis

CAPA management

Change control

Bilingual FR/EN

Formation

Bachelor's degree in science/engineering

Outils

FMEA

Description du poste

Job Title: CQV Compliance Specialist (F/M/D)

Type de contrat: CDD

Lieu : Toulouse

Département : MSAT/CQV

We’re excited to share this opportunity is part of the Sandoz acquisition of Just-Evotec Biologics in Toulouse. Through this opportunity you will impact the lives of hundreds of millions of people through bold ideas supported by an inclusive, agile company culture. Join us to help make healthcare fairer and faster, help us to pioneer access to medicine!

What You’ll Do

The MSAT Compliance Specialist plays a key role in supporting compliance activities across MSAT, ensuring documentation, quality systems, and action plans are effectively managed and aligned with internal procedures and regulatory requirements.

Missions

• Coordinate and provide the required quality and compliance documentation to MSAT teams, ensuring timely access to relevant information and records;
• Act as a key partner for MSAT stakeholders in the management and follow-up of deviations, CAPAs, change controls, and related action plans;
• Lead and support investigations related to deviations, ensuring thorough root cause analysis and timely implementation of corrective and preventive actions;
• Monitor compliance trends and perform data analysis to identify improvement opportunities and support proactive decision-making;
• Coordinate and manage document lifecycle activities, including SOP updates, document revisions, and change implementation;
• Ensure the effective tracking, execution, and closure of quality records and compliance actions, fostering continuous improvement and operational excellence;
• Collaborate cross-functionally with Quality, Manufacturing, and MSAT teams to promote compliance, strengthen processes, and support business objectives.

Who You Are

• Bachelor’s degree in a scientific, engineering, or technical field, with 4-5 years of experience in a cGMP-regulated manufacturing environment.
• Fluent in French and English, with strong communication and stakeholder management skills.
• Experienced in root cause investigations (5 Whys, Ishikawa, etc.) and risk management methodologies such as FMEA.
• Solid understanding of cGMP requirements and quality systems, including deviations, CAPAs, and change controls.
• Detail-oriented, proactive, and solution-driven, with a strong commitment to quality and continuous improvement.
• Collaborative team player, able to work effectively across functions and manage multiple priorities.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.