Spécialiste scientifique principal – Nitrosamines

As a scientific specialist at Pharmascience, you will lead teams to develop strategies for controlling nitrosamine impurities in pharmaceutical products. You will conduct risk assessments to ensure compliance with health regulations and maintain global product commercialization. You will manage the lifecycle of nitrosamines, assess risks related to supplier changes, and update evaluation reports. You will also oversee risk mitigation initiatives and collaborate with internal teams and external partners to manage nitrosamine-related risks.

Responsibilities :

• Evaluate and prepare robust risk assessments for API manufacturing, excipients, and finished product manufacturing, packaging, and storage for the presence of nitrosamines and nitrosamine drug substance related impurities (NDSRIs).
• Identify potential Nitrosamine risks, formulate testing strategies for confirmatory testing for ‘at risk’ products.
• Investigate all potential root causes for impurity formation in drug products and devise risk mitigation strategies to ensure acceptable levels are achieved and meets regulatory compliance.
• Collaborate with Toxicology teams to establish appropriate acceptable intake levels for nitrosamines based on structure activity relationship (SAR), read-across and other permissible regulatory design approaches.
• Prioritize and coordinate analytical method development and validation activities for commercial products in collaboration with Royalmount and Candiac Laboratories and / or third-party testing facilities.
• Review analytical findings and prepare strategies for control, mitigation or remediation activities.
• Team up and collaborate with various cross-functional teams including Global Regulatory Affairs, Quality, Supply Chain, Global Operations, PMO, and Client Services to manage product life cycle, implement process improvement or source changes to ensure the continued compliance of marketed products.
• Evaluate supplier change controls for Nitrosamine impact assessment and update or generate new Nitrosamine risk assessments based on change assessments.
• Maintain Nitrosamine documentation database and up to date risk assessments as per current Global Health Authority regulations.
• Initiate and manage Change Controls from raw material and third-party vendors.
• Liaise with external suppliers and their quality assurance teams to coordinate confirmatory testing of nitrosamines for high-risk products and implementation of process improvement activities.
• Become subject matter expert to assess all aspects of nitrosamines.
• Keep abreast of nitrosamine current literature in the public domain and regulatory guidelines.

Skills, Knowledge and Abilities :