• Position : Sr. Associate, Quality Assurance and Compliance
  • Department : Quality Assurance
  • Requisition :
  • Job Type : Contract
  • Posting Date : 05/22/2019
  • Location : Brampton, Ontario

Taro is a multinational; science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.

Our Brampton location is presently looking for a Sr. Associate, Quality Assurance and Compliance to join our Sun Pharma Quality Assurance Department for a 12 month contract.

The Senior Associate, Quality Assurance and Compliance is responsible for execution of all compliance Programs in Sun Pharma Canada Inc. as per Health Canada requirements.  Also the individual in this role is responsible for supporting the processes associated with electronic systems used by Sun Pharma Canada Inc. 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 Sun Pharma 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 Sun Pharma 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

  • Ensure review and approval of the change control records and their appropriate content, risk-based impact assessment and associated actions
  • Ensure appropriate personnel training
  • Develop and maintain site SOP on this subject

 

Corrective Action and Preventive Action (CAPA) Program

  • Generate and maintain Quality and Compliance metrics
  • Ensure appropriate trend analysis as an outcome of the established compliance Programs and identify appropriate CAPAs to continuous improvement process
  • 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 Director, Quality Assurance
  • Develop and maintain site SOP on this subject

Knowledge, Skills and Abilities

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