Senior Quality Assurance and Compliance Associate - Brampton, Ontario Canada - 20270



JOB DESCRIPTION

Job #: 20270
Title: Senior Quality Assurance and Compliance Associate
Job Location: Brampton, Ontario - Canada
Employment Type:
Salary: contact recruiter for details
Employer Will Recruit From: Nationwide
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?


Our client located in Brampton, ON is actively looking for a qualified individual for this 6 month contract position.

JOB DESCRIPTION

Responsibilities:

  • Responsible for monitoring and executing tracking of the management strategy
  • Proficiently communicate with the company sites and CMOs while ensuring APR receipt is in line with the schedule
  • Accountable for performing analysis of provided information and add post-release product data, and issue the APR executive summary
  • Proactively identify risks while working with the product manufacturers on the corrective actions
  • Responsible for developing and maintaining site SOPs
  • Actively responsible monitoring and maintaining the quality assurance agreements with the manufacturing and packaging facilities, testing labs, appropriate vendors and distributor’s warehouse operations
  • Accountable for establishing QAA tracking system to ensure their revision and approval is done on time
  • Responsible for connecting and negotiating with the parties involved in the QAA review and approval processes
  • Effectively and efficiently work with the legal department on the review and requirements of the QAA to ensure correct language is used in the documents
  • Proficiently develop and maintain SOPs on this topic as well
  • Accountable for the global documentation implementation while reviewing the list of global quality standards and SOPs to identify the list for implementation
  • Responsible for managing the gap assessment process and ensure the completion of all implementation activities
  • Accountable for providing all completed forms for review and approval based on the outlined process
  • Effectively and efficiently ensure the review and approval of the change control records and the content, risk-based impact assessment and associated actions
  • Proactively ensure that the appropriate personnel training
  • Responsible for generating and maintaining quality and compliance metrics for the CAPA program
  • Accountable for ensuring the appropriate trend analysis as an outcome of the established compliance programs and identifying the correct CAPAs for continuous improvements
  • Proficiently own and execute the CAPAs in association with Health Canada, Internal Audit, and Self Inspection observations
  • Actively responsible for developing the Annual Audit and Self-Inspection Plan while obtaining the approval of the Associate Director, QA
  • Accountable for assigning audits to the employees based on their certification, experience and expertise
  • Effectively develop SOPs for local vendor audit and self-inspection programs

QUALIFICATIONS

Requirements:

  • Bachelor’s Degree in a related discipline such as science or pharmacy
  • 5+ years previous experience in Quality Assurance in the pharmaceutical industry working under Health Canada GMP regulations
  • Excellent communication skills, both written and verbal, in combination with technical writing, presentation, and negotiation skills
  • Previous experience working with compliance programs/ project management
  • Excellent working knowledge of GMP and regulatory requirements
  • Strong ability to handle multiple projects and meet strict deadlines
  • Excellent judgement and decision-making skills
  • Strong working ability with applicable software such as Trackwise and MS Office
  • Must possess Canadian Citizenship, Permanent Resident Status, or a Vaild Work Permit

 

***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

Education:
University - Bachelor's Degree/3-4 Year Degree

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