Senior Specialist, Risk Control
7 days ago
This position requires a presence at our office located in St-Laurent, Montreal, two days a week, on Tuesdays and Wednesdays.
Reporting to the Quality Services Manager, the main responsibility of the Senior Specialist is to provide expert quality guidance, review, approval and is the quality lead for product technology transfers and validations throughout the products’ lifecycle to ensure that all activities related to manufacturing, packaging, testing and distribution meet current regulatory standards in approved markets and company standards. The Senior Specialist QS also provides oversight and guidance for the development and validation of analytical methods.
Quality Assurance Specialist supporting product lifecycle changes stemming from increasing regulatory requirements and vendor-initiated changes.
- Support required due to an increase in activities related to change controls including unplanned vendor changes.
- Product transfers, process validations and method validations for several important projects such as Xcopri and related unplanned issues.
- Risk to quality of technical transfer (potential issues, delays, not meeting regulatory requirements) and to timing of projects (lifecycle and new product introduction such as Xcopri).
Leads in the resolution of investigations, deviations, corrective actions, and other quality issues with each CMO.
Manages change controls under their responsibility.
Performs risk assessments as necessary and identifies mitigations to reduce risks.
Ensures product transfer and validation activities meet current regulatory requirements.
Bachelor’s degree in science.
~8+ years of experience in quality and validation in a GMP environment in the pharmaceutical and/or medical device industry.
~ Strong technical writing skills and a good command of general grammar and usage.
~ Bilingual (French and English) with excellent oral and written communication skills*
Paladin Pharma strives to offer a French-speaking work environment to all its Quebec-based employees. Although, as part of its francization program, Paladin Pharma has taken all reasonable measures to avoid imposing the requirement of English, knowledge, and proficiency in English for Senior Specialist, Quality Services’ position is at an advanced level, particularly due to the need to communicate and collaborate regularly in English with English-speaking business partners outside the province of Quebec.
Retirement Savings Plan (RRSP)
Employee Assistance Program (EAP)
Free gym on site
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