Senior Specialist, Quality Services

7 days ago

Montréal QC, Canada Paladin Pharma Full time

At Paladin Pharma, we strive to offer a work environment that meets the diverse needs of our team members and advances the goals of the individual, the team and the company, while promoting flexibility, accountability and collaboration. If you're looking for a hybrid work environment, Paladin is the place for you

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.

- Back-up required due to leave of absence (attrition, maternity leave, sick leave);
current team managing daily activities and backlog.

- 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.
  • Evaluates metrics to determine trends and opportunities for continuous improvements and liaises with other departments
  • Performs risk assessments as necessary and identifies mitigations to reduce risks.
  • Ensures procedures, master product records, specifications and related documents are initiated and maintained according to product lifecycle changes.
  • Ensures product transfer and validation activities meet current regulatory requirements.
  • Recommends process improvements based on process/method validation and compliance trends.

Your Profile

  • 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.
  • Demonstrates expert knowledge and application of the principles, concepts and theories of Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs), GXP/ISO standards, concepts, regulations and industry standards.
  • Strong attention to detail.
  • Strong technical writing skills and a good command of general grammar and usage.
  • Demonstrates excellent interpersonal skills.
  • 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.

What We Offer

  • Hybrid work schedule
  • Benefits package on first day
  • Retirement Savings Plan (RRSP)
  • Employer contribution to employee RRSP (DPSP)
  • Employee Assistance Program (EAP)
  • Telemedicine program
  • Employee Referral Program ($)
  • Free gym on site
  • Free parking

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