Senior/Lead Pharmaceutical Consultant - Compliance Services

Mississauga, Ontario, Canada expand job description ↓

Description

The Lead/Senior Pharmaceutical Consultant--Compliance role focuses on applying your GMP knowledge and experience to on-site projects, such that the client is confident in the approach and timing of execution of the project. Our consultants work closely with management 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 Director and/or Manager Compliance 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


Requirements

Experience in the following is required:

  • Change Management -
  • Deviation investigations
  • Master manufacturing/batch record review and lot release
  • Data integrity improvement initiatives
  • Health Canada audit responses and remediation

Benefits

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


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


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