Senior Manager, Nitrosamine Impurities Remediation
1 month ago
As the Senior Manager, you will play a key role in overseeing the risk evaluation and remediation activities for Nitrosamine impurities at Pharmascience (PMS). Your responsibilities will include establishing the overall Nitrosamine strategy, coordinating risk assessments, and interpreting results to communicate with regulatory authorities.
Key Responsibilities:
- Develop and implement the Nitrosamine strategy
- Coordinate risk assessments, method development, and validation activities
- Communicate with regulatory authorities and stakeholders
- Lead process improvement initiatives to reduce nitrosamine impurities
- Lead the nitrosamine steering committee to report progress and establish priorities
Requirements:
- Fluent in English and French (oral and written)
- Knowledge of GMP and API manufacturing
- Financial skills to analyze and prepare budgets
- Demonstrated skills in managing multiple projects simultaneously
- Strong analytical skills and ability to summarize data
Preferred Qualifications:
- Experience in quality assurance and risk management
- Knowledge of SAP and MS Office
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