Regulatory Affairs Associate

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Irfa******

  • Canada 
  • Last Update: 07.01.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
Stellarton, CA
Country
Canada

Category


Regulatory, Quality and Clinical

Description


Core Competencies

  • Well trained in compliance procedures, policies, standards and obligations including Canadian privacy laws and import/export regulations;
  • Strong and current knowledge of ACMPR, HACCP, Food Safety, regulatory and environmental guidelines;
  • Excellent grasp on reporting procedures and record keeping;
  • Strong computer literacy to include understanding of Microsoft Office Suite, Google Suite, ADP, and Acrobat;
  • Demonstrated knowledge of quality assurance procedures and standards;

Responsibilities

  • Collaborate with other departments (e.g., Quality Assurance, Operations, Legal, and Human Resources) to direct compliance issues appropriately regarding investigation, resolution, vulnerability and risk; Serve as an integral member of the Quality Assurance team, interact cross-functionally to ensure business objectives are aligned, and ensure that the organization meets its quality and business goals
  • Deliver consistency and additional oversight in municipal, employment and general compliance and documentation across the organization; coordinate the preparation and completion of regulatory and compliance documents and ensuring the satisfaction of provincial and local government requirements at an organizational level;
  • Track deviations and compile deviation reports; communicate findings, correction strategies, and all other relevant information to the QAP and the Chief Quality and Compliance Officer;
  • Assist in development, initiation, maintenance, and revision of policies and procedures for the general operation of the Quality Assurance and Regulatory Compliance processes to prevent illegal, unethical, or improper conduct;
  • Maintain Information Management System and access controls for an effective organization-wide compliance and cross-functional record keeping system;
  • Assist in collection and management of an auditable records and files from Health Canada and GMP Audits etc.
  • Update documents as needed to address changes to laws, regulations, or company rules and obtains proper executive review and authorization prior to release;
  • Support Senior Level Management in coordinating internal compliance review activities;
  • Administrative participation in various business transactions (i.e. purchase and sale of plant materials, procurement of supplies, tools and other internal/external resources);
  • Help lead the innovation and continuous improvement of internal control frameworks, including the integration of multiple programs and compliance requirements;
  • Work extensively with highly confidential information, reviewing of permits for import and export; and
  • Other tasks as assigned by management.

Requirements

  • Bachelor

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