Quality Assurance (QA) Consultant

JR France; Grand Est; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

Rejoignez un leader mondial dans le domaine des dispositifs médicaux. Vous serez Consultant en Assurance Qualité, chargé de gérer la documentation et de veiller à la conformité aux normes GMP et ISO. Ce poste offre des opportunités de travailler sur des projets internationaux tout en collaborant avec des équipes multiculturelles.

Qualifications

• 3 ans d'expérience dans un environnement GMP industriel.
• Connaissance des normes de qualité (GMP, ISO 13485/9001).
• Capacité à rédiger des documents techniques.

Responsabilités

• Gérer la documentation qualité et effectuer des validations de processus.
• Collaborer avec les équipes de validation et de production.
• Participer à la gestion des changements liés aux processus.

Connaissances

Attention aux détails

Compétences en travail d'équipe

Connaissance des pratiques GMP

Compétences organisationnelles

Connaissances en documentation technique

Formation

Baccalauréat en sciences de la vie ou domaine connexe

Outils

TrackWise

Veeva

SAP-QM

Description du poste

Social network you want to login/join with:

Quality Assurance (QA) Consultant, grand est

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Client:

PQE Group

Location:

grand est, France

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

340620069830236569632760

Job Views:

2

Posted:

11.06.2025

Expiry Date:

26.07.2025

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Job Description:

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas.

Due to our continuous growth, we are currently looking for a Quality Assurance (QA) Consultant with 3+ years of experience in an industrial GMP environment. As a key member of the Quality Assurance (QA) team, you will support routine activities related to quality documentation, equipment qualification, and process validation. You will ensure compliance with applicable standards (GMP, ISO, etc.) and internal procedures, while closely collaborating with production, maintenance, and engineering teams.

Location: Reims, Grand Est, France

Key Responsibilities:

1. Quality Documentation Management

Draft, review, and approve protocols, reports, and procedures related to:

• Process validation (PV) and cleaning validation(CIP/SIP)

Maintain and update technical documents (SOPs, specifications) and ensure proper archiving

Support deviation investigations and the implementation of CAPAs

2. Validation Support

Collaborate with validation and production teams to:

• Verify data accuracy and regulatory compliance

Assist with periodic reviews of existing validation studies

3. Change Control Management

Participate in the assessment and implementation of change requests related to equipment, processes, or methods

Perform risk/impact analyses and monitor follow-up actions

Update affected documentation following changes

4. Additional Responsibilities

Support internal audits and regulatory inspection readiness

Contribute to continuous improvement initiatives (e.g., lessons learned, KPIs)

Monitor updates in applicable regulatory standards (GMP, FDA, EU Annex 1)

Requirements:

• Bachelor's degree in Life Sciences, or related field (or equivalent experience)
• Experience: 3+ years in an industrial GMP environment (e.g., pharmaceutical, medical devices)
• Solid knowledge of Good Manufacturing Practices and quality standards (GMP, ISO 13485/9001)
• Familiarity with the qualification/validation lifecycle (equipment/processes)
• Experience drafting technical documentation(e.g., protocols, reports)
• Knowledge of technical English (for regulatory documentation)
• Strong attention to detail, organizational skills, and a methodical approach
• Excellent teamwork skills, especially in cross-functional settings (production, engineering, RA)
• Proficiency in QA tools (e.g., TrackWise, Veeva, SAP-QM) is a plus
• Quality certifications (Six Sigma, Internal Auditor) are considered an asset

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.