Quality Assurance Associate Consultant - Pharmaceutical

Q&C • Mississauga, ON

1d

About The Position

This Pharmaceutical Consulting role focuses on applying your GMP knowledge and experience to various projects, such that the client is confident in the approach and timing of execution of the project. Our consultants work independently within a team environment to ensure activities are undertaken in a timely manner. We are looking for consultants who want to apply their in-depth quality and compliance knowledge and out-of-the-box thinking to challenging projects with our clients. Our projects cover, but are not limited to: deviation investigations, auditing, management of quality systems, delivering of training, batch document review, product releases, equipment validation, computer validation (including data integrity): related to the fabricating, packaging and testing of pharmaceuticals, biologics, NHPs and Medical Devices. Depending on your experience and career goals, the successful candidate would be placed in one of the two operational companies : Q&C Services - focuses on supporting importing projects where importing experience is an asset OR QCR - supports various quality consulting roles. In this broad-based role, you will support the projects assigned to you, meeting the client’s needs. The role specifically prioritizes, plans, organizes and executes projects related to quality and compliance of health products to ensure smooth implementations. The role may involve coordinating/working with client personnel to meet project goals.

Requirements

• Bachelors' degree in Science required
• 1 – 3 years industry experience in the following is an asset: Change/CAPA management
• 1 – 3 years industry experience in the following is an asset: Deviation investigations
• 1 – 3 years industry experience in the following is an asset: Master manufacturing/batch record review and lot release
• 1 – 3 years industry experience in the following is an asset: Annual Product Quality Reviews
• 1 – 3 years industry experience in the following is an asset: Stability review and assessment
• 1 – 3 years industry experience in the following is an asset: APQR review and assessment
• 1 – 3 years industry experience in the following is an asset: Exposure to Health Canada audits, corporate audits and self inspections

Nice To Haves

• GMP knowledge and experience
• Ability to work independently within a team environment
• In-depth quality and compliance knowledge
• Out-of-the-box thinking
• Importing experience (for Q&C Services role)
• Experience in fabricating, packaging and testing of pharmaceuticals, biologics, NHPs and Medical Devices

Responsibilities

• Prioritizing and managing compliance projects
• Completing critical assessments of data and documents to identify gaps compared to regulatory requirements
• Communicating project milestones on a monthly basis
• Completing client assigned tasks: deviation investigations, review of importer documentation
• Developing documentation as required by the project: SOPs, protocols, reports, APQRs etc.
• Releasing product to market
• Assisting with hosting Health Canada audits, corporate audits, and self inspections

Benefits

• Accommodations are available on request for candidates taking part in all aspects of the selections process.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level