Responsable Qualité Site Emplois

Responsable Qualité Site

Baxter

Emplacement:
France , Lesquin

Catégorie:
Contrôle de Qualité

Type de contrat:
Non fourni

Salaire:

Non fourni

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Description du poste:

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives. As a Site Quality Manager, you will play a key role in ensuring production activities comply with Good Manufacturing Practices (GMP) and regulatory requirements. Delegated by the Responsible Pharmacist, you will guarantee product quality and patient safety, while ensuring compliance with quality policies and EHS rules. Your mission: to be the guarantor of excellence and reliability across the entire site.

Responsabilités:

Ensure regulatory compliance: GMP and Health Code
Conduct internal audits, prepare for inspections, follow up on corrective actions, participate in supplier audits
Pilot product quality control: Guarantee the feasibility of parenteral nutrition preparation formulas (prescribed doses, physicochemical stability) and determine expiration for manufacturing
Verify the conformity of production equipment sterilization cycles
Guarantee the conformity of sampling and release of relevant raw materials and consumables
Ensure proper execution and conformity of environmental monitoring
Release finished products according to internal procedures
Manage quality assurance: Guarantee documentation conformity and participate in the procedure approval cycle
Master changes (strict application of change control procedures)
Ensure proper execution of the production unit validation plan
Manage anomalies and complaints (recording, investigation management, identification of corrective and preventive actions, incident closure)
Perform pharmacovigilance declarations if needed
Proceed, in conjunction with the Responsible Pharmacist, to lot recall if needed
Monitor and analyze site Quality indicators
Supervise and develop your team: Lead the Quality team with high standards
Develop direct reports, particularly in their quality assurance skills
Define clear objectives for the team aligned with company policy
Assess team competencies and conduct performance reviews
Communicate and convey company decisions, fostering mobilization around objectives
Enforce HR and EHS procedures
Drive continuous improvement: Define and implement, in collaboration with the Unit Manager, a continuous improvement plan for the unit
Monitor and analyze site Quality indicators
Participate and contribute to production reporting (Tier 3, Tier 4) to report on activity, propose and lead any necessary corrective actions
Participate in cross-functional improvement and organization projects
Manage and support site Quality projects and participate in site projects

Exigences:

Pharmacist registered in Section B of the Order
Experience in managing a Quality team in a pharmaceutical production environment
Key skills: mastery of GMP, asepsis, laboratory tests, rigor, leadership, complexity management
Mastery of French and English
Known for organizational qualities, dynamism, anticipation, and high standards
Constraints of the position: flexible hours, possible on-call duties

Ce que nous offrons:

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Informations supplémentaires:

Offre publiée:
16 janvier 2026

Type d'emploi:

Temps plein

Type de travail:

Travail sur site

Baxter - Toutes les offres d'emploi

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