Senior Manager, Nitrosamine Risk Evaluation and Remediation

2 months ago


Montreal, Quebec, Canada Pharmascience Full time
Senior Manager, Nitrosamine Risk Evaluation and Remediation

Pharmascience is seeking a highly skilled Senior Manager to lead our Nitrosamine risk evaluation and remediation efforts. As a key strategic driver, you will oversee the development and implementation of strategies to mitigate the presence of Nitrosamine impurities in our products.

Responsibilities:
  • Develop and execute a comprehensive Nitrosamine risk management plan
  • Coordinate risk assessments, method development, and validation activities
  • Interpret results, document investigations, and communicate with regulatory authorities as needed
  • Lead process improvement initiatives to reduce Nitrosamine impurities
  • Chair the Nitrosamine steering committee to ensure project planning, timelines, budget, and quality alignment
  • Identify necessary tests, trends, and capability options
  • Coordinate sample collection and testing protocols
  • Collaborate with external partners to advance risk analysis and testing
  • Lead recall committee meetings as required
  • Collaborate with marketing on portfolio decisions for reformulation
  • Participate in regulatory and client audits, acting as a subject matter expert
  • Ensure Risk Management Strategies are in place and maintained
Requirements:
  • Fluent in English and French (oral and written)
  • Knowledge of GMP
  • Knowledge of API manufacturing and finished product dosage forms
  • Financial skills to analyze and prepare budgets
  • Demonstrated skills in managing multiple projects simultaneously
  • Solid planning, organizational, and leadership skills
  • Ability to work under pressure and set priorities
  • Strong analytical skills and ability to summarize data
  • Competencies with MS Office and SAP


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