Regulatory and Compliance Manager

Regulatory and Compliance Manager

Oshawa, ON Job ID 202636

Company Description

A well-established production facility is looking to fulfill a key role within their organization, seeking a Regulatory and Compliance Manager to join their team to help with the maintenance of establishment licenses.

Compensation

A comprehensive compensation package is on offer, including salary, benefits, and wellness program.

Position Description

The role involves crafting regulatory approaches, along with the creation and execution of quality assurance and quality control schemes to ascertain adherence to relevant regulations, and upkeep of the Quality Management System (QMS).

• Oversees, aids, and coordinates in-house audits and inspections according to GMP standards.
• Formulates, observes, and enhances the organization’s quality structure.
• Regularly refines areas impacted by deviations and sanctions suitable CAPAs.
• Guides and supervises ongoing procedures with an application of GMP knowledge and adherence to Health Canada guidelines.
• Identifies and amends weak or inadequate processes, policy exceptions, and inconsistencies, and approves and implements corrective measures to ensure optimal quality control and assurance.
• Conducts training for newcomers.
• Organizes and carries out tasks related to quality.
• Compiles, scrutinizes, and gives the go-ahead to all quality documents and operational protocols.
• Crafts and submits product and organization Health Canada license applications to preserve compliance.
• Acts as a liaison for the organization with Health Canada or other federal regulatory bodies.

Qualifications

• Familiarity with elements of pharmaceutical GMP rules (including quality systems, cause analysis, and total quality administration).
• Understanding of GMP, along with international regulations.
• Acquaintance with relevant sections of Health Canada Regulations.

Education

Completion of undergraduate/graduate degree in pharmacy, Biotechnology or healthcare required.