Compliance Lead
SAGE Engineering
Oakville, Ontario, Canada
2d ago

SAGE Engineering Services Ltd. :

Established in 2000, SAGE Engineering Services Ltd. has consistently outpaced expectations in terms of its growth and capabilities.

Our team is a blend of industry experienced engineers, technicians, project management professionals, and operations staff.

We serve medium to large organizations in regulated industries throughout North America and internationally, in sectors such as : pharmaceutical, biotechnology, healthcare, medical devices, nutraceutical, cosmetics, and food and beverage.

  • At SAGE, we believe in providing our clients with key personnel, having the background and experience to integrate with your project team;
  • Working with our clients rather than for them. Our strategic partnerships provide our clients with full service teams for specific project needs, offering flexible working arrangements to meet project demands.

    Roles and Responsibilities :

  • Reporting to the Quality Project Manager.
  • Providing direction and feedback on regulatory items / guidelines to SAGE team members, functional departments, supervisors, managers, and engineers, as required.
  • Coordinates the planning, organization, control, and completion of validation and quality compliance projects.
  • Maintain knowledge based of current industry practice and regulation developments in all areas of Validation and Quality.
  • Prepare and execute (as applicable) project documentation, including URSs, SOPs, Commissioning protocols, and Validation (IQ / OQ / PQ) protocols.
  • Organizes and provides direction and support to project staff according to project requirements.
  • Provides regular status updates to customer and SAGE on projects; both technical and financial.
  • Coordinates activities concerned with technical developments, scheduling, and resolving design or test problems.
  • Controls expenditures within limitations of project budget, prepares interim and completion project reports.
  • Participate in business development for Validation and Quality Compliance initiatives. Actively seeks new project work with clients, prepares and submits project proposals.
  • Qualifications :

  • Degree in Science or Engineering
  • 5+ years of related regulated industry experiences (preferable pharmaceutical experience).
  • Strong project management principles (knowledge and experience).
  • In-depth knowledge of pharmaceutical and engineering principles and practices.
  • Strong work ethic, excellent interpersonal skills, organizations, verbal, and written communication skills.
  • Strong knowledge of regulations (Health Canada, FDA, GMPs, GPP, etc.)
  • Proficient MS Office applications such as Word, Excel, PowerPoint, Project.
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