!! We have the biggest portfolio in Canada from CellGene therapy to Biosimilars. Allowing us to lead in the aplication of the GxP and ensure compliance in a proactive way. This role supports the excellence of our quality system enabling the compliance of our whole portafolio and allowing curiosity of our teams through their training plans. One of the main drivers of this position is to keep our associates trainining plans updated to ensure eveyone in the company is up to date on the latest advances and state of the art. Also isbe single point of contcat for prcoedures implementation and simplification.
Your responsibilities include, but are not limited to:
• Manages Quality aspects and projects within area of responsibility.
• Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.
• Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner.
• Support and track the implementation and maintenance of the local Quality system in in accordance with the Novartis Quality Manual.
• Manages processes and systems for all GxP Quality Assurance e.g. Change control, Training Management, Escalation Management, Risk Management. Ensures that processes are conducted in full compliance with the GxP and the Novartis Quality.
• Contributes to an improvement of current processes and/or to an implementation of modified processes.
• Ensures adequate tracking and on time completion of corrective and preventive actions (CAPA), inc escalation of issue related to the closure of CAPA, as appropriate.
• Review quality deliverables to ensure compliance, with health authority requirements and SOPs, including procedural documents, records, third party work, contractors, clinical trial material, components, and gap assessments.
What you’ll bring to the role:
• Bachelor in Science or equivalent. 3-5 years’ experience in Pharmaceutical, Biotech or equivalent.
• Sound knowledge of GxP
• Ability to communicate and write reports clearly.
• Knowledge of Pharmaceutical operations regarding manufacturing processes and chemical formulations (2-3 years).
• Initiative, self-motivation and superior organizational and time management skills.
• Excellent English Speaking and writing skills, French speaking and writing is an asset.
Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme. Find out more about Novartis Canada: https://www.novartis.ca/
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!