Job title:
Senior Manager, nitrosamine project
Company
Pharmascience
Job description
Description :As the Senior Manager, you will act as a key strategic driver who will oversee the risk evaluation and remediation activities for Nitrosamine impurities for Pharmascience (PMS).Responsibilities:
- Establish the overall Nitrosamine strategy
- Coordinate the risk assessments preparation, method development and validation and product testing activities
- Interpretate the results, document the investigations, assess market actions requirements and communicate with the regulatory authorities when required
- Lead the process improvement initiatives to reduce presence of nitrosamines impurities in PMS products
- Lead the nitrosamine steering committee to report progress and establish priorities, ensuring alignment in project planning, timelines, budget, & project quality
- Identify the necessary tests to be performed, trends which may influence future limits
- Review capability options and best location to perform these tests effectively.
- Coordinate sample collection, prepare testing protocols.
- Work with external partners to ensure advancement of risk analysis, testing exécution and implementation of process improvement.
- Lead the recall committee meeting when required.
- Based on interpretation, collaborate with marketing on portfolio decisions if reformulation is required for a product
- Participate in regulatory and client audits. Act as SME.
Ensure that Risk Management Strategies are in place and maintained to ensure continued marketing of Pharmascience products worldwideSkills, knowledge and abilities:
- Fluent in English & French (oral & written), since the role requires to interact with regulatory authorities, suppliers and clients located outside the province of Quebec.
- Knowledge of GMP
- Knowledge of API manufacturing and finished product dosage forms (Solids, semi-solids, liquid dosages) and manufacturing and packaging processes
- Financial skills to be able to analyze and prepare budget
- Demonstrated skills in managing multiple projects simultaneously
- Solid planning, organizational skills, teamwork, leadership and agile project management
- A positive approach to change and proven aptitude for initiative and innovation
- Time management and effective communication with multi-disciplinary team members
- Ability to anticipate problems and propose solutions
- Ability to work under pressure and set priorities
- Collaboration and team spirit
- Strong analytical skills and ability to summarize vast amounts of data
- Capacity to effectively manage time and priorities
- Competencies with MS Office, SAP
Education : Bachelor
MasterExperience : 10 years: experience in the pharmaceutical industry in Management/Laboratory/Production or equivalent
Expected salary
Location
Montreal, QC
Job date
Sat, 14 Sep 2024 22:58:50 GMT
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