Associate, Quality Services

2 weeks ago

Montréal, Canada Endo International Full time

At Paladin, we believe that flexibility can have a positive impact. That's why our employees have the power to choose when and where they are most productive and effective. If you are looking for an opportunity to work from home for a fast-paced organization, Paladin is the place for you

This position requires a presence at our office located in St-Laurent, Montreal, one day per week, depending on operational needs.

Position Summary

The Associate, Quality Services responsibility is to assist the Quality Services team in the following areas: change management, quality documentation updates and general quality support. He will interact with other team members and external partners to support quality initiatives as required per applicable regulations all while ensuring compliance of quality systems and our products

Reports To

Manager, Quality Services

Specific Responsibilities
- Responsible for documentation controls in the Quality Management System (QMS).
- Initiate change requests related to Paladin products and systems in the QMS.
- Maintain control on the change management system by obtaining assessments, approvals and documentation from internal and external partners.
- Review and approve documentation related to the change management system.
- Assist with SOP review and metrics as needed.
- Attention to detail
- Excellent interpersonal skills
- Organizational skills
- Ability to establish and maintain effective working relationships
- Communication
- Service oriented

Required
- Bachelor’s Degree in sciences or DEC in health-related science combined with relevant work experience.
- Minimum of 2 years’ experience in a GXP environment in the pharmaceutical or medical device industry.
- Demonstrates an understanding of fundamental GMP terminology, concepts, regulations and industry standards.
- Knowledge of records and data management systems/processes and tools.
- Knowledge of Good Documentation Practices.
- Bilingualism (French and English), oral and written.
- Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading._

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