Senior Manager, nitrosamine project

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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