Job Description

Summary

The CQV Specialist ensures the control, compliance, availability, and integrity of all documentation subject to GMP requirements in order to maintain site regulatory compliance and operational traceability. They check that all quality-related documents are created, reviewed, approved, distributed, and archived in accordance with applicable procedures.

Duties and responsibilities

Quality Master Plan Documentation - Draft and maintain:

• Draft and maintain:
• Standard Operating Procedures (SOPs)
• Work Instructions
• Internal « Quality Master Plan » updates
• « Project Validation Plan » updates
• « Change Control Management » procedure

Project-Specific GMP Documentation

• Prepare project-specific quality documentation
• FAT, SAT, IQ, and OQ protocols

Support to Project Managers During FAT & SAT Activities

• Prepare FAT activities and pre-testing
• Support the Project Manager during FAT execution
• Follow up on non-conformities
• Prepare qualification reports

Additional Responsibilities

• Deliver GMP and GDP training and awareness activities
• Support the preparation of internal and external audit

Rédaction de documents du « Quality Master Plan » :

• Procédure de travail (SOP)
• Instruction de travail
• Mise à jour du « Quality Master Plan » interne
• Mise à jour du « Project Validation Plan »
• Procédure de « Change Control Managment»

Rédaction de la documentation GMP spécifique projet:

• Rédaction du plan de qualité spécifique à un projet
• Réalisation des protocoles FAT/SAT/IQ/OQ

Assistance aux responsables de projets durant les FAT&SAT :

• Préparation de la FAT et des tests préliminaires
• Accompagnement du responsable de projet durant la FAT
• Suivi des non-conformités
• Rapport de qualification

Tâches annexes et supplémentaires

• Formation et sensibilisation pour GMP et GDP
• Préparer les audits internes et externes

Required Experience

• Minimum 5 years of experience in GMP documentation, validation, quality assurance, or a regulated pharmaceutical/biotech/medical device environment.
• Experience creating and managing GMP documentation (SOPs, protocols, reports, validation plans, quality plans).
• Experience supporting FAT, SAT, IQ, and OQ activities.
• Experience working within Change Control, Deviation, CAPA, and Document Management systems.
• Experience supporting internal and external audits and regulatory inspections.

Skills & Competencies

• Strong knowledge of GMP, GDP, and validation requirements.
• Excellent technical writing and document control skills.
• Ability to review, organize, and maintain complex documentation packages.
• Strong attention to detail and compliance mindset.
• Effective communication and collaboration with Quality, Engineering, Automation, and Project Management teams.
• Strong organizational and prioritization capabilities.
• Problem-solving and root cause analysis skills.
• Ability to work independently while managing multiple projects and deadlines.

Languages

• English: Professional working proficiency (required)
• French: fluent (required)

Key Performance Indicators (KPIs)

• On-time completion of GMP documentation deliverables.
• Percentage of documentation approved without major rework.
• Closure rate of documentation review comments.
• Timely completion of FAT/SAT/IQ/OQ/PQ documentation packages.
• Number of overdue documentation actions.
• Audit observations related to documentation compliance.
• Change Control documentation closure performance.
• Reduction in documentation errors, deviations, or recurring compliance observations.
• Audit findings closure rate.