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.
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