Quality Assurance Specialist

Laboratory Validation Specialists, Inc. - Ottawa, ON (il y a 30+ jours)

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Quality Assurance Specialist

Hourly Rate: $45-50/hr

Contract Location: Toronto, ON

Who are we?

Laboratory Validation Specialists, Inc. is an American-based consulting resource provider for cGMP regulatory compliance in North America, Europe, and Asia for pharmaceutical, biotechnology, and medical device companies.

Job Description

  • Using the approved requirements traceability matrix with the identified remediation items, create a detailed re-qualification plan (remediation plan) for each process skid / utility system
  • Working with the equipment vendor, author and review the re-qualification protocol for the process skid / utility system
  • Oversee and execute re-qualification protocols with support of vendor, production and other applicable departments (including Qualification Team)
  • Provide daily review and feedback of qualification activities under execution to ensure any issues are addressed promptly
  • Author and review the re-qualification reports for the process skid and utility system
  • Author and review and execute performance qualification protocols, reports
  • Process engineering background required for technical review of vendor documents and oversight on protocol execution

The duration of the project is expected to be 3 months to start (all of the protocol generation + initial work with vendors on site from April through June). Based on vendor availability execution might extend into the third quarter.

As for work visas: The client issues invitation letters based on the project and approved purchase order/contract.

Job Type: Contract

Salary: $45.00 to $50.00 /hour

Experience:

  • Pharmaceutical, medical device, or cosmetics: 5 years (Required)
  • Quality Assurance: 5 years (Required)