Manager, Quality Assurance and Compliance - Brampton, Ontario Canada - 20301



JOB DESCRIPTION

Job #: 20301
Title: Manager, Quality Assurance and Compliance
Job Location: Brampton, Ontario - Canada
Employment Type:
Salary: contact recruiter for details
Employer Will Recruit From: Local
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?


Our client in Brampton is looking to fill a 6-month position for Manager, Quality Assurance and Compliance who will be responsible for management and execution of all compliance Programs as per Health Canada requirements. The individual in this role is responsible for management of the processes associated with electronic systems used by the organization. The Manager, 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

JOB DESCRIPTION

·        Manage Annual Product Review Program:

·        Develop 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

·        Develop and maintain Quality Assurance Agreements

·        Develop 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

·        Responsible for 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 Management 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 in global QMS Trackwise

*    Corrective Action and Preventive Action (CAPA) Program o Develop and maintain Quality and Compliance metrics o Ensure appropriate trend analysis as an outcome of the established compliance Programs and identify appropriate CAPAs to continuous improvement process o Own and execute CAPAs associated with Health Canada, Internal Audit and Self-Inspection observations

*    Local Vendor Audit and Self-Inspection Program

·        Develop Annual Audit and Self-Inspection Plan and obtain approval of the Associate Director, Quality

Assurance

·       

 
   

Assign audits to the certified company employees based on their certification, experience and expertise

 

·        Develop and maintain site SOP on this subject

QUALIFICATIONS

·        Minimum University level degree (B.Sc.) in a Science or Pharmacy discipline applicable to Health Canada standards

·        Minimum 7+ 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

*    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

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