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Senior Associate QA & Compliance

Contract Full Time
  • Contract
  • Full Time
  • Brampton

Career Connections Canada Inc.

'Connecting great people with great companies'

Our pharmaceutical client in Brampton is seeking a qualified Senior Associate QA & Compliance to join their team on a full-time, contractual basis.

General Summary:

The Senior Associate, Quality Assurance and Compliance is responsible for execution of all compliance Programs as per Health Canada requirements. Also the individual in this role is responsible for supporting the processes associated with electronic systems used by the organization. The Sr. Associate, Quality Assurance and Compliance is also responsible for execution of all CAPAs associated with Health Canada inspections, internal audit and self-inspection program ensuring their timely closure and effectiveness check.

Principal Duties and Responsibilities:

  • Execute Annual Product Review Program:
  • Monitor and execute tracking management strategy
  • Communicate with company sites and CMOs and ensure APR receipt as per the schedule
  • Perform analysis of the provided information and add post-release product data, issue APR Executive

Summary

  • Identify risks and work with the product manufacturers on the corrective actions
  • Develop and maintain site SOP on this subject
  • Review, develop, enhance and maintain Quality Assurance Agreements
  • Monitor and maintain the list of all required Quality Assurance Agreements with manufacturing and packaging facilities, testing laboratories, applicable vendors and distributor’s warehouse operations
  • Establish QAA tracking system to ensure their timely revision and approval
  • Connect and negotiate with the parties involved into the QAA review and approval process
  • Affiliate with the company’s Legal department on review and requirements of the QAA to ensure appropriate language in the documents
  • Develop and maintain site SOP on this subject
  • Execution of Global Documentation Implementation
  • Review the list of the global Quality Standards and SOPs and identify the list for implementation
  • Manage gap assessment process and ensure completion of all implementation associated activities
  • Provide all completed forms for review and approval as per the established process
  • Change Control Program Execution to Ensure review and approval of the change control records and their appropriate content, risk-based impact assessment and associated actions o Ensure appropriate personnel training o Develop and maintain site SOP on this subject
  • Corrective Action and Preventive Action (CAPA) Program o Generate Quality and Compliance metrics
  • Ensure appropriate trend analysis as an outcome of the established compliance Programs and identify appropriate CAPAs to continuous improvement process o Execute CAPAs associated with Health Canada, Internal Audit and Self-inspection observations

Local Vendor Audit and Self-Inspection Program

  • Support develop of the Annual Audit and Self-Inspection Plan and obtain approval of the Associate
  • Develop and maintain site SOP on this subject

Knowledge, Skills and Abilities:

  • Minimum University level degree (B.Sc.) in a Science or Pharmacy discipline applicable to Health Canada standards
  • Minimum 5+ years of experience in Quality Assurance department working under Health Canada GMP regulations
  • Excellent communication skills (written and oral) including presentation skills, technical writing, organization and negotiation skills
  • Compliance Programs/Project management experience is an asset
  • Proven problem-solving ability with evidence of good judgment and decision-making skill
  • Strong organizational ability and management of multiple priorities combined with proven ability to meet strict and established timelines
  • Excellent working knowledge of GMP and regulatory requirements for the pharmaceutical industry
  • Strong proficiency with applicable computer software

***Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections

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