Assurance Qualité (AQ) coordonnateur(trice) validation
- Knowlton, QC, Canada
Full-time
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Job details
- Job type
- Full-time
- Apply by
- Positions available
- 1
- Posting language
- English · French
- Posted
Original job description
English section of this bilingual listing.
At KDC/ONE, we are leaders in contract manufacturing and the largest manufacturer of deodorants in North America. At the heart of our values is excellence, which motivates us to make every effort to realize the projects of our clients. In addition to our major specializations, we continuously strive to innovate to design more than a thousand other beauty, health and hygiene products.
The mission we are proposing:
Under the supervision of the Quality Assurance Supervisor, the QA Validation Coordinator ensures the consistency, rigor and compliance of validation strategies within kdc/one Knowlton. The incumbent is responsible for coordinating and managing validation activities for equipment, systems and processes to ensure compliance with regulatory and quality requirements. He/she acts as a liaison between the technical and operational teams to support the implementation and maintenance of robust and sustainable practices.
What You Need to Know About This Position
- Employment Status: Temporary – Full-Time (indefinite duration)
- Work Schedule: Day shift, 8-hour schedule
- Number of Positions Available: 1
- Work Location: Knowlton
- Start Date: As Soon As Possible
An overview of your new position
- Collaborate in the development of validation strategies and approve them for equipment qualification, process and packaging validation, computer system validation, cleaning validation and systems validation (i.e., water, HVAC, positive pressure, etc.);
- Maintain Validation Master Plans, protocols and reports to ensure they are audit-ready and compliant with Health Canada and FDA requiremen
ts. - Collect and analyze data from executed validation activities to ensure that all parameters meet specified requirements;
- Develop, review and approve protocols, reports and work instructions to ensure rigorous execution in accordance with GMP requirements;
- Participate in change management activities impacting validated processes to maintain the integrity of validations in place;
- Coordinate revalidation/requalification activities with Operations and customers, when required, in accordance with Standard Operating Procedures (SOPs);
- Act as a resource person during internal and external audits to demonstrate the robustness of validation strategies;
- Collaborate with the Quality, Production and Technical Services teams to ensure the consistent and sustainable application of validation requirements, and act as the primary point of contact for customers regarding validation activities;
- Perform the Annual Drug Product Review in accordance with specific customer requirements and internal SOPs;
- Perform any other related duties as assigned by the immediate supervisor, based on operational needs.
You are the ideal candidate if you have
- Bachelor of Science degree (required);
- Minimum of three (3) to five (5) years of experience in a regulated Environment (GMP), including a thorough understanding of validation;
- Thorough knowledge of Good Manufacturing Practices (GMP);
- Proficiency in computer tools (Office suite, AS400, LIMS or similar systems);
- Bilingualism (French and English).
Bilingualism is required in order to communicate with certain team members and internal partners, as well as to understand and interpret technical documentation and client requirements.
What we have to offer you
- Bonus program based on company performance and meeting your goals
- Comprehensive group insurance program including; prescription drugs, dental, vision, and more
- Short and long-term disability insurance
- RRSP: We contribute up to 4% of your salary, matching your contribution
- Access to telemedicine service and employee support program including sleep resources
- Receive quality, custom personal protective equipment
- Opportunities for advancement and internal mobility to develop your potential
- Rigor and critical thinking in risk analysis and decision-making.
- Autonomy and proactivity in information research and problem solving;
- Ability to mobilize and consult with technical experts in order to obtain the necessary information;
- Ability to influence and collaborate with multidisciplinary teams without hierarchical authority;
- Ability to effectively organize and manage priorities in an ever-changing environment;
- Attention to detail and commitment to quality and compliance;
Does the challenge speak to you? To learn more and apply, it’s right here…
Read the full bilingual original
Chez KDC/ONE, nous sommes des leaders dans la fabrication en sous-traitance et le plus grand fabricant de déodorants en Amérique du Nord. Au cœur de nos valeurs réside l'excellence, ce qui nous motive à tout mettre en œuvre pour réaliser les projets de nos clients. En plus de nos spécialisations majeures, nous nous efforçons continuellement d'innover pour concevoir plus de mille autres produits de beauté, de santé et d'hygiène.
La mission qu’on te propose:
Sous la supervision du Superviseur Assurance Qualité, le/la AQ Coordonnateur(trice) validation assure la cohérence, la rigueur et la conformité des stratégies de validation au sein de kdc/one Knowlton. Le/la titulaire du poste assure la coordination et la gestion des activités de validation des équipements, des systèmes et des procédés afin de garantir leur conformité aux exigences réglementaires et aux exigences qualité. Il/elle agit comme point de liaison entre les équipes techniques et opérationnelles afin de soutenir la mise en place et le maintien de pratiques robustes et durables.
Ce qu’il faut savoir sur ce poste :
- Statut : Temporaire – Temps plein (durée indéterminée)
- Horaire : quart de jour horaire de 8 heures
- Nombre de postes à pourvoir: 1
- Lieu de travail : Knowlton
- Entrée en fonction : Dès que possible
- Collaborer à l’élaboration des stratégies de validation et les approuver pour la qualification des équipements, la validation des procédés et du conditionnement, la validation des systèmes informatisés, la validation du nettoyage ainsi que la validation des systèmes (ex. : eau, HVAC, pression positive, etc.) ;
- Maintenir les plans de validation (Validation Master Plans), les protocoles et les rapports afin de s’assurer qu’ils soient prêts pour les audits et conformes aux exigences de Santé Canada et de la FDA ;
- Recueillir et analyser les données issues des activités de validation exécutées afin de s’assurer que tous les paramètres respectent les exigences spécifiées ;
- Élaborer, réviser et approuver des protocoles, rapports et instructions de travail afin d'assurer une exécution rigoureuse conforme aux exigences GMP ;
- Participer aux activités de gestion du changement ayant un impact sur les procédés validés afin de maintenir l’intégrité des validations en place ;
- Coordonner les activités de revalidation/requalification avec les Opérations et les clients, lorsque requis, conformément aux procédures opératoires normalisées (SOP) ;
- Agir à titre de personne-ressource lors des audits internes et externes afin de démontrer la robustesse des stratégies de validation ;
- Collaborer avec les équipes de la qualité, de la production et des services techniques afin d’assurer une application cohérente et durable des exigences de validation, et agir à titre de personne-ressource principale auprès des clients pour les activités de validation ;
- Effectuer la revue annuelle des produits pharmaceutiques (Annual Drug Product Review) en collaboration avec les exigences spécifiques des clients et les procédures opératoires normalisées (SOP) internes;
- Effectuer toute autre tâche connexe assignée par le superviseur immédiat selon les exigences opérationnelles.
- Baccalauréat en sciences (requis);
- Minimum de trois (3) à cinq (5) ans d’expérience dans un environnement réglementé (GMP), incluant une compréhension approfondie des activités de validation ;
- Maîtrise des bonnes pratiques de fabrication (GMP) ;
- Maîtrise des outils informatiques (suite Office, AS400, LIMS ou systèmes similaires) ;
- Bilinguisme (français et anglais).
Ce que nous avons à t’offrir :
- Programme de bonification basé sur les résultats de l'entreprise et l'atteinte de tes objectifs
- Programme d’assurance collective complet incluant; médicaments, soins dentaire, vision et plus encore
- Assurance invalidité courte et longue durée
- REER : Nous cotisons jusqu’à 4% de ton salaire, correspondant à ta contribution
- Accès à un service de télémédecine et à un programme d’aide aux employés incluant ressource au sommeil
- Bénéficiez d’équipement de protection individuel de qualité et sur mesure
- Possibilités d'avancement et de mobilité interne pour développer ton potentiel
At KDC/ONE, we are leaders in contract manufacturing and the largest manufacturer of deodorants in North America. At the heart of our values is excellence, which motivates us to make every effort to realize the projects of our clients. In addition to our major specializations, we continuously strive to innovate to design more than a thousand other beauty, health and hygiene products.
The mission we are proposing:
Under the supervision of the Quality Assurance Supervisor, the QA Validation Coordinator ensures the consistency, rigor and compliance of validation strategies within kdc/one Knowlton. The incumbent is responsible for coordinating and managing validation activities for equipment, systems and processes to ensure compliance with regulatory and quality requirements. He/she acts as a liaison between the technical and operational teams to support the implementation and maintenance of robust and sustainable practices.
What You Need to Know About This Position
- Employment Status: Temporary – Full-Time (indefinite duration)
- Work Schedule: Day shift, 8-hour schedule
- Number of Positions Available: 1
- Work Location: Knowlton
- Start Date: As Soon As Possible
- Collaborate in the development of validation strategies and approve them for equipment qualification, process and packaging validation, computer system validation, cleaning validation and systems validation (i.e., water, HVAC, positive pressure, etc.);
- Maintain Validation Master Plans, protocols and reports to ensure they are audit-ready and compliant with Health Canada and FDA requiremen
ts.
- Collect and analyze data from executed validation activities to ensure that all parameters meet specified requirements;
- Develop, review and approve protocols, reports and work instructions to ensure rigorous execution in accordance with GMP requirements;
- Participate in change management activities impacting validated processes to maintain the integrity of validations in place;
- Coordinate revalidation/requalification activities with Operations and customers, when required, in accordance with Standard Operating Procedures (SOPs);
- Act as a resource person during internal and external audits to demonstrate the robustness of validation strategies;
- Collaborate with the Quality, Production and Technical Services teams to ensure the consistent and sustainable application of validation requirements, and act as the primary point of contact for customers regarding validation activities;
- Perform the Annual Drug Product Review in accordance with specific customer requirements and internal SOPs;
- Perform any other related duties as assigned by the immediate supervisor, based on operational needs.
- Bachelor of Science degree (required);
- Minimum of three (3) to five (5) years of experience in a regulated Environment (GMP), including a thorough understanding of validation;
- Thorough knowledge of Good Manufacturing Practices (GMP);
- Proficiency in computer tools (Office suite, AS400, LIMS or similar systems);
- Bilingualism (French and English).
What we have to offer you
- Bonus program based on company performance and meeting your goals
- Comprehensive group insurance program including; prescription drugs, dental, vision, and more
- Short and long-term disability insurance
- RRSP: We contribute up to 4% of your salary, matching your contribution
- Access to telemedicine service and employee support program including sleep resources
- Receive quality, custom personal protective equipment
- Opportunities for advancement and internal mobility to develop your potential
- Rigor and critical thinking in risk analysis and decision-making.
- Autonomy and proactivity in information research and problem solving;
- Ability to mobilize and consult with technical experts in order to obtain the necessary information;
- Ability to influence and collaborate with multidisciplinary teams without hierarchical authority;
- Ability to effectively organize and manage priorities in an ever-changing environment;
- Attention to detail and commitment to quality and compliance;
More about this job
Responsibilities
Coordinate and manage validation and revalidation activities for equipment, systems, and processes, including developing and maintaining validation strategies, plans, protocols, and reports. Support audits, change management, annual drug product reviews, and collaboration with quality, production, technical teams, and customers to maintain regulatory and GMP compliance.
Requirements
A bachelor's degree in science is required, along with three to five years of experience in a regulated GMP environment and a thorough understanding of validation. Candidates must be proficient with computer tools such as Office, AS400, or LIMS, and be bilingual in French and English.
Skills
- Validation Strategy
- Equipment Qualification
- Process Validation
- Packaging Validation
- Computer System Validation
- Cleaning Validation
- Validation Master Plans
- Good Manufacturing Practices
- Regulatory Compliance
- Data Analysis
- Change Management
- Audit Support
- Annual Drug Product Review
- Risk Analysis
- Cross-Functional Collaboration
- Microsoft Office, AS400, and LIMS
Benefits
- Performance-Based Bonus
- Comprehensive Group Health Insurance
- Prescription Drug Coverage
- Dental Insurance
- Vision Insurance
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- Retirement Savings Plan With Employer Matching Up to 4%
- Telemedicine Services
- Employee Assistance Program
- Custom Personal Protective Equipment
- Advancement and Internal Mobility Opportunities
Visa sponsorship
Not detected in the job text
Categories
- Manufacturing
- Science & Research
- Management & Leadership
Keywords
- Good Manufacturing Practices
- Validation
- Equipment Qualification
- Process Validation
- Packaging Validation
- Computer System Validation
- Cleaning Validation
- Water Systems
- HVAC
- Validation Master Plan
- Health Canada
- FDA
- Standard Operating Procedures
- Change Management
- Revalidation
- Requalification
- Internal Audits
- External Audits
- Annual Drug Product Review
- Risk Analysis
- Microsoft Office
- AS400
- LIMS
- Quality Assurance
- Regulatory Compliance
- Personal Care Product Manufacturing