Quality Assurance (AQ) Validation Coordinator

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 requirements.

• 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…

FOLLOW US ON : Facebook/ LinkedIn/ Instagram/ Site Web

REASON FOR WORKING IN EASTERN TOWNSHIPS:

• Here is the perfect balance. The dynamic balance that we all seek between the realization of our personal and professional dreams. The balance between proximity to major centers, with all the urbanity they provide, and rurality with its generous nature and diversified activities.
• Here, 40,000 students learn and develop skills through nearly 900 post-secondary programs and training and more than 100 vocational training programs. A wealth that generates creativity, a taste for going beyond and opening up to the world.
• Here, it is also health through the practice of activities of all kinds and through healthy lifestyles. Here, the playground is huge and nearby: peaks, trails, rivers, lakes, infrastructures and sports clubs. Whether you are a Sunday athlete or a high level athlete, you will find something to keep you in shape!
• Here, the landscapes of the Townships are varied and its nature is generous: lakes, rivers, mountains, vines, marshes, conifers, deciduous trees, valleys. Our bucolic landscapes encourage contemplation and letting go. In the fall, the landscapes ignite to create a panorama typical of southern Quebec.

** To simplify the text, the masculine is used in a neutral sense. Kdc/one is an equal employment opportunity employer for visible minorities and women. **