94207
Québec, QC
Permanent/Direct Hire
4 days ago
DESCRIPTION DE POSTE
Poste : Spécialiste en validation – L1/L2
Type : Permanent
Localisation : Québec – Hybride
Sommaire
Notre partenaire recherche un(e) spécialiste en validation responsable de créer, mettre à jour et maintenir la documentation de validation associée à des systèmes de sérialisation et d’inspection d’emballage utilisés notamment dans l’industrie pharmaceutique.
La personne contribuera à assurer la conformité, la qualité et la fiabilité des systèmes en travaillant étroitement avec les équipes internes et les clients.
Responsabilités
- Développer et maintenir les gabarits de validation
- Produire les documents de validation à partir des spécifications fonctionnelles et de conception
- Créer des plans de tests adaptés aux besoins des clients
- Participer à l’exécution des protocoles de validation
- Évaluer l’impact des mises à jour et changements apportés aux systèmes
- Participer aux analyses de risques
- Identifier les causes des non-conformités de validation et contribuer aux actions correctives
- Collaborer avec les différents départements aux étapes clés des projets
- Conseiller les équipes internes et les clients sur les pratiques et stratégies de validation
- Collaborer avec l’assurance qualité
- Participer aux audits internes et externes
- Contribuer à l’amélioration continue des processus de validation
Compétences recherchées
- Minimum 2 ans d’expérience en validation/test de systèmes ou rédaction technique
- Formation collégiale pertinente ou expérience équivalente
- Excellentes capacités rédactionnelles
- Anglais écrit avancé et oral intermédiaire
- Maîtrise de Microsoft Office, notamment Word et Excel
- Rigueur, esprit analytique et souci du détail
- Curiosité et volonté d’apprendre
- Excellentes capacités de collaboration
- Connaissance des environnements réglementés, un atout
- Expérience IQ/OQ/PQ ou qualification d’équipements, un atout
JOB DESCRIPTION
Position: Validation Specialist – L1/L2
Type: Permanent
Location: Québec – Hybrid
Summary
Our partner is looking for a Validation Specialist responsible for creating, updating, and maintaining validation documentation associated with serialization and packaging inspection systems used primarily in the pharmaceutical industry.
The successful candidate will help ensure the compliance, quality, and reliability of systems by working closely with internal teams and clients.
Responsibilities
- Develop and maintain validation templates
- Produce validation documents based on functional and design specifications
- Create test plans tailored to client requirements
- Participate in the execution of validation protocols
- Assess the impact of system updates and changes
- Participate in risk assessments
- Identify the causes of validation non-conformities and contribute to corrective actions
- Collaborate with various departments at key stages of projects
- Advise internal teams and clients on validation practices and strategies
- Collaborate with Quality Assurance
- Participate in internal and external audits
- Contribute to the continuous improvement of validation processes
Required Skills
- Minimum 2 years of experience in system validation/testing or technical writing
- Relevant college-level education or equivalent experience
- Excellent writing skills
- Advanced written English and intermediate spoken English
- Proficiency in Microsoft Office, particularly Word and Excel
- Strong attention to detail, analytical mindset, and thoroughness
- Curiosity and willingness to learn
- Excellent collaboration skills
- Knowledge of regulated environments is an asset
- Experience with IQ/OQ/PQ or equipment qualification is an asset
The pay range that the employer reasonably expects to pay for this position is between CA$60,000 and CA$75,000
Our voluntary benefits offering includes medical, dental, vision and retirement benefits.
This posting is for an existing vacancy.
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Tundra Technical Solutions is a global workforce and technology delivery firm, ranked by Staffing Industry Analysts as one of the largest in North America. At Tundra, we aren't just hiring top talent at the world's most recognizable brands; we are pioneers of social recruitment. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other legally protected characteristics. We welcome and encourage diversity in the workplace.
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