22 Oct
|
Septodont
|
Cambridge
22 Oct
Septodont
Cambridge
At Septodont, a global leader in dental products and a key player in pharmaceutical development and contract manufacturing (CDMO), we are proud to work every day to improve patients’ health and well-being.
Present in more than 110 countries, the Group relies on the energy, expertise, and passion of 2,600 employees. With 6 international production sites, Septodont combines industrial excellence, technological expertise, and innovation to meet the needs of healthcare professionals worldwide.
In North America, our operations include facilities in Ontario, Quebec, and Pennsylvania. Our Cambridge, Ontario site is home to Novocol Pharma – a thriving center of innovation with over 40 years of expertise in sterile injectable cartridges and combination product manufacturing. Backed by a team of more than 675 dedicated professionals and modern facilities, we deliver high-quality, customer-focused solutions to partners around the world.
Beyond our expertise, our people are our greatest strength. We foster a stimulating work environment where everyone can learn, grow, and build a career that reflects their aspirations, supported by continuous training and internal mobility. As a socially responsible company, we place diversity and inclusion at the heart of our development, convinced that they enhance collective performance and foster human experience.
Joining Septodont means becoming part of a human-scale international group and contributing to a meaningful mission: improving health for as many people as possible. What if your next professional chapter started with us?We have an opportunity for a Quality Systems & Continuous Improvement Specialist in Cambridge, ON.
FUNCTION SUMMARYThe Quality Systems & Continuous Improvement Specialist is accountable to the Senior Manager,
Quality and is responsible for providing quality and compliance leadership within a cross-functional continuous improvement team. The Quality Systems & Continuous Improvement Specialist will partner with Production, Engineering, Technical Services, Validation, and Quality personnel to identify, prioritize, and implement improvements that enhance manufacturing performance, product quality, and quality system effectiveness.
The Quality Systems & Continuous Improvement Specialist will provide quality oversight and regulatory guidance for continuous improvement initiatives and quality event management activities. This role will lead and support investigations, risk assessments, and corrective and preventive actions (CAPAs) to ensure issues are effectively resolved and improvements are implemented in a compliant and sustainable manner.
Success in this position requires a strong presence on the manufacturing floor, actively observing processes, engaging with operators and technical staff, identifying emerging issues and opportunities, and applying critical, cutting-edge thinking to drive practical and effective solutions. The incumbent will leverage GMP and regulatory requirements using a risk-based approach, balancing quality, compliance, operational performance, and business objectives. In addition, this role will be instrumental in accelerating the maturation of newly implemented procedures and quality system processes, ensuring they are robust, effective,
and sustainable components of the organization’s Quality Management System.
PRIMARY DUTIES AND
RESPONSIBILITIES:
Partner with Production, Engineering, Technical Services, Validation, and Quality teams to identify and implement improvements to manufacturing processes, equipment, systems, and procedures that enhance product quality, process capability, and operational performanceMaintain a strong presence within manufacturing operations to develop a thorough understanding of processes, identify improvement opportunities, and support sustainable operational and quality excellence.
Provide quality and regulatory guidance to cross-functional teams and continuous improvement initiatives, ensuring compliance with GMP regulations, industry standards, and regulatory expectations.
Review and assess proposed process, equipment, facility, and procedural changes for quality and regulatory impact.
Apply critical thinking, scientific analysis, risk-based decision making, and structured problem-solving methodologies to investigate issues, identify root causes, challenge conventional approaches, and develop effective solutions.
Lead and/or facilitate investigations related to deviations, complaints, audit observations, environmental monitoring excursions, and other quality events, ensuring investigations are thorough, scientifically sound, and completed within established timelines.
Lead and/or support the development, implementation, effectiveness verification, and on-time closure of corrective and preventive actions (CAPAs) and other quality event actions.
Lead and/or facilitate quality risk assessments and ensure quality risks are appropriately identified, evaluated, and mitigated.
Monitor and trend manufacturing and quality system
📌 Quality Systems (Cambridge)
🏢 Septodont
📍 Cambridge