Quality Assurance Specialist

Full Time posted 1 month ago

Job Description

INDUSTRY: Healthcare

SUMMARY:

Merit Services Ltd. is looking for professionals who want to apply their compliance knowledge and out-of-the-box thinking to challenging projects with our clients. This role specifically prioritizes, plans, organizes and executes projects related to the quality and compliance of health products to ensure smooth implementations.

RESPONSIBILITIES:

  •  Reporting to the VP Quality Services and/or Manager Quality Services, the Lead/Senior Consultant is responsible for:
  •  Establishing project plans that capture all aspects of the scope of work
  •  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, management of quality systems, review of documentation
  •  Developing documentation as required by the project: SOPs, protocols, reports, etc.
  •  Conducting audits both internal and external
  •  Releasing products to market
  •  Hosting Health Canada audits 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.

REQUIRED:

  •  Importation
  •  Change Management
  •  Deviation investigations
  •  Master manufacturing/batch record review and lot release
  •  Health Canada audit responses Annual Product Quality Reviews
  •  Stability review and assessment
Change Management Deviation Investigations Importation
 
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