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Quality Assurance Specialist-Associate Consultant-Pharmaceutical

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Location: Hornby
Company: Q&C
Hours: Full time

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The Associate Consultant—Compliance Services 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.

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.

Reporting to the Manager, Quality Services or Compliance Services the Associate Consultant is responsible for:

  • 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

If you are a Quality Assurance professional in the Pharmaceutical industry, we have the environment and exposure to the type of work you want to do.

Requirements

1 – 3 years industry experience in the following is required:

  • Change/CAPA management
  • Deviation investigations
  • Master manufacturing/batch record review and lot release
  • Annual Product Quality Reviews
  • Stability review and assessment
  • APQR review and assessment
  • Exposure to Health Canada audits, corporate audits and self inspections

Benefits

Learn about what makes our company unique at www.qualityandcompliance.com

Q&C welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selections process.

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